Axial lengthening thrombus capture system

ABSTRACT

Systems and methods can remove material of interest, including blood clots, from a body region, including but not limited to the circulatory system for the treatment of pulmonary embolism (PE), deep vein thrombosis (DVT), cerebrovascular embolism, and other vascular occlusions.

PRIORITY CLAIM

This application claims the benefit under 35 U.S.C. § 120 as acontinuation application of U.S. patent application Ser. No. 15/604,531filed on May 24, 2017, which is continuation-in-part application of U.S.patent application Ser. No. 15/428,076 filed on Feb. 8, 2017, which is acontinuation-in-part application of U.S. patent application Ser. No.15/230,109 filed on Aug. 5, 2016, which claims the benefit under 35U.S.C. § 119(e) as a nonprovisional application of each of U.S.Provisional App. Nos. 62/202,074 filed on Aug. 6, 2015, 62/273,418 filedon Dec. 30, 2015, and 62/345,863 filed on Jun. 6, 2016. Each of theaforementioned priority applications is hereby incorporated by referencein their entireties.

BACKGROUND Field of the Invention

The invention relates to, in some aspects, systems and methods to removematerials of interest, including blood clots, from a body region,including but not limited to the circulatory system for the treatment ofpulmonary embolism (PE), deep vein thrombosis (DVT), cerebrovascularembolism, and other vascular occlusions.

Description of the Related Art

It is understood that undesirable materials such as blood clots (whichcould be referred to as thrombi, thromboemboli, or emboli herein) in theblood vessels may partially or completely occlude blood vessels in areasof the coronary, cerebrovascular, pulmonary, peripheral venous, andperipheral arterial circulation resulting in myocardial infarction,stroke, pulmonary embolism, deep vein thrombosis, and infarction of anextremity respectively.

Various therapies and devices are known to either dissolve, debulkand/or aspirate the thromboemboli. For instance, anticoagulant agentssuch as heparin and warfarin help stabilize blood clots and preventfurther forming of clots while thrombolytic agents such as urokinase,streptokinase, and tPA assist in dissolving blood clots. These agentscan be delivered via systemic infusion or catheter-based infusion to theintended location. While thrombolytic agents can be effective indissolving blood clots, they require a long time duration in order forthe agents to dissolve the blood clots; thus patients may need to remainin the hospital intensive care unit (ICU) during thrombolytic infusion.Relatively long lengths of stay can increase healthcare costssignificantly. A major limitation for these thrombolytic agents is thatthey can potentially cause intracranial, gastrointestinal,retroperitoneal, and pericardial bleeding, among other sites, which canbe often life-threatening and cause significant morbidity and mortalityrisks.

Mechanical debulking and/or aspiration devices can be used to remove theobstruction. These mechanical techniques can either macerate, aspirate,or a combination thereof in order to remove the blood clots. Anadvantage of mechanical therapy is that it can remove thrombus directlyfrom the blockage area and immediately eliminates the obstruction andmay be superior to thrombolytic agents in some cases. However, currentmechanical therapies have some major limitations. There is minimal to noflow during the procedure thus there is little time before patients maybecome hemodynamically instable. The debris removed from mechanicaltreatment can travel distally creating additional embolization. Thesmall size devices are unable to remove large amount of blood clots inshort time periods thus patients may become hemodynamically instable.

Catheter-based removal of blood clots from larger blood vessels (e.g.,pulmonary arteries) have had limited success compared to smaller bloodvessels (e.g., coronary arteries). Catheter pulmonary embolectomy iswhere pulmonary emboli are removed percutaneously using severaltechniques. Fragmentation thrombectomy breaks blood clots into smallerpieces, most of which travel further downstream, resulting in distalembolization. It is sometimes used in combination with thrombolytics.With the rheolytic thrombectomy, high velocity saline jets create aVenturi effect and draw the fragments of the clot into the catheter.This method poses risk of hemolysis. Finally the aspiration techniquesdraw the clot into a catheter via suction. All of these techniques relyon the catheter used to remove the clots from blood vessels. The usersuse small catheters to remove or break up large amounts of blood clot.This procedure is therefore time-consuming and inefficient. Once theblood clots are broken into small pieces, the debris can migratedistally and create unwanted emboli. Rheolytic therapy poses the risk ofhemolysis. Additionally, the ability to suction is limited due the smallcatheter size suctioning large emboli. These limitations cause in somecases unnecessary duress to the user and risk to the patient.

Catheter-based removal of blood clots in general also has a majorlimitation when distal working space within a body lumen is limited.Conventional devices may require full axial and/or radial deployment andexpansion to be functional, and as such flexibility to use such devicesfor a variety of clinical situations involving differing clot or othermaterial sizes to be removed can be very limited. Therefore, conditionswhere there is limited distal space of blood vessels can render theseconventional devices ineffective.

It is evident that all of the therapeutic options available to patientswith blood clots or other undesirable material in blood vessels andother body lumens have limitations. Anticoagulation only limitspropagation of clots but does not actively remove it. Thrombolytictherapy poses a risk of major bleeding. Catheter embolectomy is noteffective to manage removal of material in large vessels. Additionally,these devices require distal space to fully deploy to be functional thusineffective in tight distal spaces. Surgical embolectomy can be highlyeffective but highly invasive, and has a high rate of morbidity andmortality. There is a need for a direct mechanical treatment that is asor more effective as surgical embolectomy removing large blood clots butcan be performed using endovascular techniques and restore immediateblood flow, and cause a lower incidence of complications.

SUMMARY

In some embodiments, disclosed herein is a capture system for selectedmaterials within a body. The capture system can include a captureassembly configured to isolate unwanted material, e.g., a blood clotthat can include a shape memory body such as made of, for example, amesh material and having a distal end connected to a capture guidehaving a distal opening. The shape memory body can further include aproximal end connected to a first shaft, and a tubular sidewall betweenthe proximal end and the distal end. The capture assembly can beconfigured to expand the capture guide and the distal opening end whenthe shape memory body proximal end is compressed in the delivery system.The shape memory body can be movable from a first configuration having afirst axial length and a second configuration having a second axiallength. The shape memory body can be configured to roll out, invert,evert, and/or variably lengthen proximally or distally from the firstconfiguration to the second configuration. The second axial length canbe different from the first axial length. The width of the captureassembly can, in some cases not substantially change from the firstconfiguration to the second configuration. The capture system can alsoinclude a control line configured to independently move the captureassembly from the first configuration to the second configuration. Thefirst shaft can extend within the longitudinal axis of the captureassembly.

In some embodiments, disclosed herein is a material, e.g., a clotcapture system. The system can include a first, outer tubular shaftcomprising a central lumen, the first outer tubular shaft comprising aproximal portion and a distal portion, the distal portion more radiallyexpandable than the proximal portion. The system can also include asecond tubular shaft configured to be positioned within the centrallumen of the first shaft. The system can also include a third tubularshaft configured to be positioned within a central lumen of the secondshaft. The shape memory tubular body can include a first end, a secondend, and an axial length therebetween, the first end having aproximal-facing opening and a ring-shaped capture guide attached to acircumference of the proximal-facing opening, the capture guide operablyattached to the second tubular shaft, the second end attached to anouter wall of the third tubular shaft. The shape memory tubular body canbe compressed within the central lumen of the second tubular shaft in afirst delivery configuration. The shape memory tubular body can betransformable to a second configuration in which the first end and thecapture guide is radially expanded up to a dynamic fold point, but thesecond end and a segment of the shape memory tubular body extends in adifferent direction, such as proximally past the dynamic fold point, andremains radially compressed within the central lumen of the secondtubular shaft and the second end is positioned proximal to the first endand the shape memory tubular mesh body has a first expanded axiallength. The shape memory tubular body can be transformable to a thirdconfiguration in which the shape memory tubular body has a secondexpanded axial length greater than the first expanded axial length, anda width of the shape memory tubular shaft along its second expandedaxial length is the same or substantially the same as a width of theshape memory tubular shaft along its first expanded axial length. Thefirst tubular shaft can be configured to be reversibly coupled withrespect to the second tubular shaft in the delivery configuration andaxially movable with respect to the third tubular shaft in the secondconfiguration. In some embodiments, the second expanded axial length isabout or at least about, for example, 105%, 110%, 115%, 120%, 125%,130%, 150%, 200%, 250%, 300%, 350%, 400%, 450%, 500%, or more of thefirst axial length. The capture system of claim 1, wherein the shapememory body can be porous, semi-permeable, and non-porous, and includenitinol braided, woven, or non-woven mesh, or nitinol wire. In someembodiments, the tubular body is coated with a hydrophilic orhydrophobic agent, or noncoated, and may not include a shape memorymetal or material. In some embodiments, the tubular mesh body isconfigured to invert, evert, or roll out with respect to the first,second, and/or third shaft. The system can also include a control lineextending proximally from the capture guide, either terminating on asleeve on one of the shafts or extending proximally to the proximal endof the system. In some embodiments, the system includes a suctionelement configured to operably connect with the proximal opening of theshape memory tubular body. The system can also include a mechanicalthrombectomy element, such as a macerator. The system can also include afilter collection chamber configured to collect and filter bloodobtained from the suction element.

The system can further include an expanding guide catheter configured toreceive the capture assembly in the form of a kit. The expanding guideelement can include an open funnel distal tip, that can be porous insome embodiments to allow flow around the funnel distal tip.

In some embodiments, disclosed herein is a material, such as a clotcapture system that can include a first, outer tubular shaft comprisinga central lumen; a second tubular shaft configured to be positionedwithin the central lumen of the first shaft, the second tubular shaftcomprising a proximal portion and a distal portion, the distal portionmore radially expandable than the proximal portion; a third tubularshaft configured to be positioned within a central lumen of the secondshaft; a tubular mesh comprising a first end, a second end, and an axiallength therebetween, the first end having a proximal-facing opening anda ring-shaped capture guide attached to a circumference of theproximal-facing opening, the capture guide operably attached to thesecond tubular shaft, the second end attached to an outer wall of thethird tubular shaft. The tubular mesh can be compressed within thecentral lumen of the second tubular shaft in a delivery configuration.The tubular mesh can also be transformable to a second configuration inwhich the first end and the capture guide is radially expanded but thesecond end and a portion, such as a minority, half, or a majority of thetubular mesh remains radially compressed within the central lumen of thesecond tubular shaft and the second end is positioned proximal to thefirst end and the tubular mesh has a first expanded axial length. Thetubular mesh can be transformable to a third configuration in which thetubular mesh has a second expanded axial length greater than the firstexpanded axial length, wherein a width of the tubular mesh along itssecond expanded axial length is substantially the same as a width of thetubular mesh along its first expanded axial length, wherein the thirdtubular shaft extends distally through the proximal end opening as wellas the second axial expanded length of the shape memory tubular body. Insome embodiments, the tubular mesh is not under tension or substantiallyunder tension in the second configuration or the third configurationdefining an axial working range of the tubular mesh.

In some embodiments, a material, such as a clot capture system includesa first, outer tubular shaft comprising a central lumen; a secondtubular shaft configured to be positioned within the central lumen ofthe first shaft, the second tubular shaft comprising a proximal portionand a distal portion, the distal portion more radially expandable thanthe proximal portion; a third tubular shaft configured to be positionedwithin a central lumen of the second shaft; a tubular body that mayinclude shape memory materials that includes a first end, a second end,and an axial length therebetween, the first end having a proximal-facingopening and a ring-shaped capture guide attached to a circumference ofthe proximal-facing opening, the capture guide operably attached to thesecond tubular shaft via a sleeve circumscribing a portion of the secondtubular shaft, the second end attached to an outer wall of the thirdtubular shaft. The shape memory tubular body can be compressed withinthe central lumen of the second tubular shaft in a deliveryconfiguration. The shape memory tubular body can be transformable to asecond configuration by axial movement of the second tubular shaft withrespect to the first tubular shaft, in which the first end and thecapture guide is radially expanded but the second end and a segment ofthe shape memory tubular body remains radially compressed within thecentral lumen of the second tubular shaft and the second end ispositioned proximal to the first end and the shape memory tubular meshbody has a first expanded axial length. The shape memory tubular bodycan be transformable to a third configuration by movement of the secondtubular shaft with respect to the third tubular shaft, in which theshape memory tubular body has a second expanded axial length greaterthan the first expanded axial length, wherein a width of the shapememory tubular shaft along its second expanded axial length issubstantially the same as a width of the shape memory tubular shaftalong its first expanded axial length, wherein the third tubular shaftextends distally through the proximal end opening as well as the secondaxial expanded length of the shape memory tubular body. The shape memorytubular body can, in some cases, be transformable to a fourthconfiguration by movement of the second tubular shaft with respect tothe third tubular shaft. The shape memory tubular body can have a thirdexpanded axial length greater than the second expanded axial length,wherein a width of the shape memory tubular shaft along its thirdexpanded axial length is less than the width of the shape memory tubularshaft along its second expanded axial length. The clot capture systemcan also include a sleeve that includes a metal or polymer, and thesleeve can be partially or fully radiopaque or radiolucent underfluoroscopy or other imaging.

Also disclosed herein is a method of performing a thrombectomy. Themethod can include, for example, accessing the interior of a bloodvessel; advancing a thrombus capture device comprising a captureassembly through the blood vessel; positioning the thrombus capturedevice such that a distal end of the device is distal to the thrombus;actuating the capture assembly to isolate the thrombus within thecapture device, wherein the capture assembly is movable from a firstconfiguration having a first axial length and a second configurationhaving a second axial length, the second axial length being differentfrom the first axial length, wherein the width of the capture assemblydoes not substantially change from the first configuration to the secondconfiguration; and suctioning, macerating, and/or mechanically removingthe thrombus.

In some embodiments, a method of performing a thrombectomy can include,for example, accessing the interior of a blood vessel; advancing anexpanding guiding catheter through the blood vessel; positioning theexpanding guiding catheter such that a distal end of the device isproximal to a thrombus; retracting the expanding guide catheter outermember to expand a funnel tip and exposing an expandable inner member;advancing a thrombus capture device comprising a capture assemblythrough the expanding guide catheter; positioning the thrombus capturedevice such that a distal end of the device is distal to or within thethrombus; and actuating the capture assembly to isolate the thrombuswithin the capture device. The capture assembly can be movable from afirst configuration having a first axial length and a secondconfiguration having a second axial length, the second axial lengthbeing different from the first axial length. The width of the captureassembly may not substantially change from the first configuration tothe second configuration. The method can also include retracting thecapture assembly with the thrombus into an expanding guide catheterfunnel tip and expandable inner body. The method can also includeaxially lengthening the thrombus capture device distally and retractingthe thrombus into the funnel tip of the expanding guide catheter. Themethod can further include radially shortening the thrombus capturedevice to compress the thrombus and promote removal of the thrombus.

In some embodiments, disclosed herein is a clot capture system that caninclude a capture assembly configured to isolate a blood clot. Thesystem can include a shape memory body that has a distal end connectedto a capture guide comprising a distal or proximal opening. The shapememory body can also include a proximal end connected to a first shaft,and a sidewall between the proximal end and the distal end. The captureguide and the distal zone of the shape memory body opening end can alsobe fully or partially recaptured inside the outer sheath. The captureassembly can be configured to radially expand the capture guide and adistal zone of the shape memory body opening end while the shape memorybody proximal end remains compressed in the delivery configuration. Thecapture assembly can be movable from a first configuration having afirst axial length to a second configuration having a second axiallength. The shape memory body can be configured to roll out, invert,evert, and/or variably lengthen proximally from the first configurationto the second configuration. The second axial length can be differentfrom the first axial length. The width of the capture assembly can insome cases not substantially change from the first configuration to thesecond configuration.

Also disclosed herein is a capture assembly configured to isolate ablood clot including a shape memory body including a proximal end and adistal end connected to a capture guide including a distal opening, aproximal end connected to a shaft, and a sidewall between the proximalend and the distal end. The capture assembly can be configured to expandthe capture guide and the distal shape memory body opening end while theshape memory body proximal end is compressed in the deliveryconfiguration between a first shaft and a second shaft, and movable froma first configuration having a first axial length and a secondconfiguration having a second axial length. The shape memory body can beconfigured to roll out/unroll, invert, evert, and/or variably lengthenproximally from the first configuration to the second configuration. Thesecond axial length can be different from the first axial length. Insome cases, the width of the capture assembly does not substantiallychange from the first configuration to the second configuration.Furthermore, the shape memory body can be fully or partially recapturedinside the outer sheath once deployed. The system can also include asleeve coupled a control line connected to the second shaft configuredto move the capture assembly from the first configuration to the secondconfiguration. The first shaft and the second shaft can be off-axis withrespect to the capture assembly.

Also disclosed herein is a method of performing a thrombectomy. Themethod can include any number of the following: accessing the interiorof a blood vessel; advancing a thrombus capture device comprising acapture assembly through the blood vessel; positioning the thrombuscapture device such that a distal end of the device is distal to thethrombus; actuating the capture assembly to isolate the thrombus withinthe capture device, wherein the capture assembly is movable from a firstconfiguration having a first axial length and a second configurationhaving a second axial length, the second axial length being differentfrom the first axial length, wherein the width of the capture assemblydoes not substantially change from the first configuration to the secondconfiguration; and suctioning the thrombus.

In some embodiments, the methods can include any number of thefollowing: accessing the interior of a blood vessel; advancing anexpanding guiding catheter through the blood vessel; positioning theexpanding guiding catheter such that a distal end of the device isproximal to a thrombus; retracting the expanding guide catheter outermember to expand a funnel tip and exposing an expandable inner member;advancing a thrombus capture device comprising a capture assemblythrough the expanding guide catheter; positioning the thrombus capturedevice such that a distal end of the device is distal to or within thethrombus; actuating the capture assembly to isolate the thrombus withinthe capture device, wherein the capture assembly is movable from a firstconfiguration having a first axial length and a second configurationhaving a second axial length, the second axial length being differentfrom the first axial length wherein the width of the capture assemblydoes not substantially change from the first configuration to the secondconfiguration; and retracting the thrombus into an expanding guidecatheter funnel tip and expandable inner body. In some embodiments, thecapture guide is first recaptured into the outer sheath of the deliverycatheter and then retract into the expanding guide catheter funnel tipand expandable inner body.

In some embodiments, disclosed herein is a clot capture system. Thesystem can include a first tubular member comprising a central lumen.The system can include a second tubular member. The system can include ashape memory tubular body comprising a first end, a second end, and anaxial length therebetween, the first end having an end opening, thesecond end attached to the second tubular member. In some embodiments,at least part of the shape memory tubular body is compressed within thecentral lumen of the first tubular shaft in a first deliveryconfiguration. In some embodiments, the shape memory tubular body istransformable to a second configuration in which the first end isradially expanded while the second end and a majority of the shapememory tubular body remains radially compressed within the central lumenof the first tubular shaft and the second end is positioned proximal tothe first end and the shape memory tubular body has a first expandedaxial length. In some embodiments, the shape memory tubular body istransformable to a third configuration via movement of the first tubularshaft with respect to the second tubular shaft in which the shape memorytubular body has a second expanded axial length greater than the firstexpanded axial length, wherein a width of the shape memory tubular bodyalong its second expanded axial length is substantially the same as awidth of the shape memory tubular body along its first expanded axiallength.

The system can include a capture guide attached to the first endopening. In some embodiments, the capture guide at least partiallycircumscribes the first end opening. In some embodiments, the captureguide fully partially circumscribes the first end opening. The systemcan include an expandable cover element circumscribing the captureguide. In some embodiments, the expandable cover element is inflatable.The system can include a control line extending proximally from thecapture guide. The system can include a sleeve attached to the firsttubular shaft and the first end opening of the shape memory tubularbody. In some embodiments, the shape memory tubular body is configuredto invert, evert, or roll out with respect to the first tubular shaft orthe second tubular shaft. In some embodiments, the end opening of theshape memory tubular body is proximal-facing. In some embodiments, theshape memory tubular body comprises a mesh. In some embodiments, theshape memory tubular body is configured to allow fluid flowtherethrough. In some embodiments, the second tubular member comprises acentral lumen. The system can include an expanding guide elementconfigured to receive the capture assembly. In some embodiments, theexpanding guide element comprises an open funnel distal tip. In someembodiments, the open funnel distal tip is porous to allow flow. In someembodiments, the shape memory tubular body has a maximal length ofbetween about 0.5 cm and about 125 cm. In some embodiments, the shapememory tubular body is transformable to a fourth configuration whereinthe shape memory tubular body has a third axial expanded length greaterthan the second axial expanded length, wherein a width of the shapememory tubular body along its third expanded axial length is less thanthe width of the shape memory tubular body along its second expandedaxial length.

In some embodiments, disclosed herein is a system for capturing materialof interest within a body lumen. The system can include a first tubularmember comprising a central lumen. The system can include a secondtubular member. The system can include a shape memory tubular bodycomprising a first end, a second end, and an axial length therebetween,the first end having an end opening, the second end attached to an outerwall of the second tubular member. In some embodiments, the shape memorytubular body is compressed within the central lumen of the first tubularshaft in a first delivery configuration. In some embodiments, the shapememory tubular body is transformable to a second configuration in whichthe first end opening and a first segment of the shape memory tubularbody extending axially in a first direction from the first end openingis radially expanded to a fold point, while a second segment of theshape memory tubular body extends axially from the fold point to thesecond end of the shape memory tubular body in a second directionopposite the first direction, the second segment relatively radiallycompressed with respect to the first segment, the second end positionedproximal to the first end. In some embodiments, the shape memory tubularbody is transformable to a third configuration via movement of the firsttubular shaft with respect to the second tubular shaft in which theaxial length of the first segment increases by a first amount, the shapememory tubular body has a second expanded axial length greater than thefirst expanded axial length, wherein a width of the shape memory tubularbody along its second expanded axial length is substantially the same asa width of the shape memory tubular body along its first expanded axiallength.

In some embodiments, disclosed herein is a clot capture system. Thesystem can include a first tubular member comprising a central lumen.The system can include a second tubular member. The system can include ashape memory tubular body comprising a first end, a second end, and anaxial length therebetween, the first end having an end opening, thesecond end attached to an outer wall of the second tubular member. Insome embodiments, the shape memory tubular body is compressed within thecentral lumen of the first tubular shaft in a first deliveryconfiguration. In some embodiments, the shape memory tubular body istransformable to a second configuration in which the first end openingand a first segment of the shape memory tubular body extending axiallyin a first direction from the first end opening is radially expanded toa fold point, while a second segment of the shape memory tubular bodyextends axially from the fold point in a second direction opposite thefirst direction to the second end, the second segment radiallycompressed with respect to the first segment, the second end positionedproximal to the first end. In some embodiments, the shape memory tubularbody is transformable to a third configuration via movement of the firsttubular shaft with respect to the second tubular shaft in which theaxial length of the first segment increases by a first amount, the shapememory tubular body has a second expanded axial length greater than thefirst expanded axial length, wherein a width of the shape memory tubularbody along its second expanded axial length is substantially the same asa width of the shape memory tubular body along its first expanded axiallength.

In some embodiments, disclosed herein is a clot capture system. Thesystem can include an outer sheath comprising a central lumen. Thesystem can include a dual lumen shaft configured to be positioned withinthe central lumen of the outer sheath. The system can include an innerpusher configured to be positioned within a first lumen of the duallumen shaft. The system can include an anchor pusher configured to bepositioned within a second lumen of the dual lumen shaft. The system caninclude an anchor coupled to the anchor pusher. The system can include ashape memory tubular body comprising a first end, a second end, and anaxial length therebetween, the first end having an opening and a captureguide attached to a portion of the opening. In some embodiments, theshape memory tubular body and the anchor are compressed in a firstconfiguration. In some embodiments, the shape memory tubular body istransformable to a second configuration in which the first end and thecapture guide are radially expanded but the second end and a majority ofthe shape memory tubular body remains radially compressed within thelumen of the dual lumen shaft and the shape memory tubular body has afirst expanded axial length with a first cross-section, wherein thefirst cross-section is substantially similar to the cross-section of thecapture guide. In some embodiments, the shape memory tubular body istransformable to a third configuration in which the shape memory tubularbody has a second expanded axial length greater than the first expandedaxial length, wherein the shape memory tubular body encapsulates theanchor in the third configuration.

The system can include, for example, one, two, or more anchors. Theanchors can have any desired configuration to stabilize or associatewith a clot to facilitate removal, including a J-hook shape in somecases. The anchors can penetrate a clot or other material to be capturedin some embodiments, or do not penetrate but rather circumscribe orotherwise stabilize or reversibly secure at least a portion of the clotor other material to be captured. In some embodiments, the anchors havea central longitudinal axis that is coaxial. The system can includethree anchors, or more. In some embodiments, the cross-section of theanchor is round, ovoid, square, rectangular, or another cross section.In some embodiments, the anchor comprises nitinol. In some embodiments,the anchor forms an angle with the anchor pusher, wherein the angle isapproximately 90 degrees. In some embodiments, the anchor forms an anglewith the anchor pusher, wherein the angle is approximately 45 degrees.In some embodiments, the anchor forms an angle with the anchor pusher,wherein the angle is between 5 degrees and 135 degrees. In someembodiments, the diameter of the anchor is less than the diameter of theshape memory tubular body when radially expanded. In some embodiments, aportion of the anchor pusher is crescent shaped. In some embodiments,the capture guide comprises nitinol. In some embodiments, the captureguide comprises a central longitudinal axis and wherein the dual lumenshaft is offset from the central longitudinal axis. In some embodiments,the second end of the shape memory tubular body is coupled to the innerpusher. In some embodiments, the capture guide forms a continuous loop.In some embodiments, the capture guide forms a non-continuous loop.

In some embodiments, disclosed herein is a clot capture system. Thesystem can include an inner pusher. The system can include a shapememory tubular body comprising a first end, a second end, and an axiallength therebetween, the first end having an opening and a capture guideattached to at least a portion of the opening, the second end coupled tothe inner pusher. In some embodiments, the shape memory tubular body andthe capture guide are compressed in a first configuration. In someembodiments, the shape memory tubular body is transformable to a secondconfiguration in which the first end and the capture guide are radiallyexpanded but the second end and a majority of the shape memory tubularbody remains radially compressed and the shape memory tubular body has afirst expanded axial length with a first cross-section, wherein thefirst cross-section is substantially similar to the cross-section of thecapture guide. In some embodiments, the shape memory tubular body istransformable to a third configuration in which the shape memory tubularbody has a second expanded axial length greater than the first expandedaxial length. In some embodiments, the capture guide forms a continuousloop. In some embodiments, the capture guide forms a non-continuousloop.

Also disclosed herein is a method of using a clot capture system. Themethod can include any number of the following: positioning a systemnear a blood clot in the first configuration; transforming the shapememory tubular body to the second configuration; and transforming theshape memory tubular body to the third configuration to encapsulate theclot. The system can include an inner pusher. The system can include ashape memory tubular body comprising a first end, a second end, and anaxial length therebetween, the first end having an opening and a captureguide attached to at least a portion of the opening, the second endcoupled to the inner pusher. In some embodiments, the shape memorytubular body and the capture guide are compressed in a firstconfiguration. In some embodiments, the shape memory tubular body istransformable to a second configuration in which the first end and thecapture guide are radially expanded but the second end and a majority ofthe shape memory tubular body remains radially compressed and the shapememory tubular body has a first expanded axial length with a firstcross-section, wherein the first cross-section is substantially similarto the cross-section of the capture guide. In some embodiments, theshape memory tubular body is transformable to a third configuration inwhich the shape memory tubular body has a second expanded axial lengthgreater than the first expanded axial length. In some embodiments, theblood clot is within the CNS.

Also disclosed herein is a method of using a clot capture system. Themethod can include any number of the following: positioning a systemnear a blood clot; transforming the shape memory tubular body to thesecond configuration; expanding the anchor; and transforming the shapememory tubular body to the third configuration to encapsulate theanchor. The system can include an outer sheath comprising a centrallumen. The system can include a dual lumen shaft configured to bepositioned within the central lumen of the outer sheath. The system caninclude an inner pusher configured to be positioned within a first lumenof the dual lumen shaft. The system can include an anchor pusherconfigured to be positioned within a second lumen of the dual lumenshaft. The system can include an anchor coupled to the anchor pusher.The system can include a shape memory tubular body comprising a firstend, a second end, and an axial length therebetween, the first endhaving an opening and a capture guide attached to a portion of theopening. In some embodiments, the shape memory tubular body and theanchor are compressed in a first configuration. In some embodiments, theshape memory tubular body is transformable to a second configuration inwhich the first end and the capture guide are radially expanded but thesecond end and a majority of the shape memory tubular body remainsradially compressed within the lumen of the dual lumen shaft and theshape memory tubular body has a first expanded axial length with a firstcross-section, wherein the first cross-section is substantially similarto the cross-section of the capture guide. In some embodiments, theshape memory tubular body is transformable to a third configuration inwhich the shape memory tubular body has a second expanded axial lengthgreater than the first expanded axial length, wherein the shape memorytubular body encapsulates the anchor in the third configuration. In someembodiments, deploying the anchor comprises securing the anchor withinthe clot. In some embodiments, transforming the shape memory tubularbody to the third configuration to encapsulate the anchor furthercomprises encapsulating the clot. In some embodiments, the blood clot isa neurological blood clot.

In some embodiments, disclosed herein is a clot capture system. Thesystem can include a first tubular member comprising a central lumen.The system can include a second tubular member. The system can include aplurality of axially spaced-apart anchors extending radially outwardlyfrom the first tubular member or the second tubular member. The systemcan include a shape memory tubular body comprising a first end, a secondend, and an axial length therebetween, the first end having an endopening, the second end attached to the second tubular member. In someembodiments, at least part of the shape memory tubular body iscompressed within the central lumen of the first tubular shaft in afirst delivery configuration. In some embodiments, the shape memorytubular body is transformable to a second configuration in which thefirst end is radially expanded while the second end and a majority ofthe shape memory tubular body remains radially compressed within thecentral lumen of the first tubular shaft and the second end ispositioned proximal to the first end and the shape memory tubular bodyhas a first expanded axial length. In some embodiments, the shape memorytubular body is transformable to a third configuration via movement ofthe first tubular shaft with respect to the second tubular shaft inwhich the shape memory tubular body has a second expanded axial lengthgreater than the first expanded axial length, wherein a width of theshape memory tubular body along its second expanded axial length issubstantially the same as a width of the shape memory tubular body alongits first expanded axial length.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates examples of a catheter system, and various possibleelements that can be included in a material capture system, according tosome embodiments of the invention.

FIG. 2 illustrates a close-up view of the thrombus capture systems ofFIGS. 1 and 2.

FIG. 3 illustrates an axially-lengthening thrombus capture (ALTC) systemin the initial deployment configuration with the ALTC device expanded,according to some embodiments of the invention.

FIG. 4 illustrates a close up view of the ALTC system distal segmentposition in the delivery configuration indicating the outer sheath andnose tip, according to some embodiments of the invention.

FIG. 5 illustrates the distal end of an axial lengthening thrombuscapture device at the initial deployment position, according to someembodiments of the invention.

FIG. 6 illustrates the axial lengthen thrombus capture device retractingproximally to deploy and lengthen, according to some embodiments of theinvention.

FIG. 7 illustrates the axial lengthen thrombus capture device is fullydeployed and the funnel tip of the guide catheter is positioned withinthe ALTC device, according to some embodiments of the invention.

FIGS. 8 and 9 illustrate different views of the initial deploymentposition of the ALTC Device and the funnel tip of the suction catheter,according to some embodiments of the invention.

FIG. 10 illustrates the partially deployed ALTC Device, according tosome embodiments of the invention.

FIG. 11 illustrates an ALTC device deployed configuration where thefunnel tip of the suction catheter is positioned inside the ALTC device,according to some embodiments of the invention.

FIG. 12 illustrates the Axial Lengthening Thrombus Capture (ALTC)assembly wherein the distal end of the ALTC device is in the expanded(deployed) configuration and is fixed to the thrombus capture guide andcapture pullwire, according to some embodiments of the invention. Forpurpose of illustration, the proximal end is in a collapsedconfiguration and extends proximally.

FIG. 13 illustrates the axial lengthening thrombus capture device in theinitial deployed configuration, according to some embodiments of theinvention.

FIG. 14 illustrates the thrombus capture element of the ALTC device thatcan include a stent or braided mesh, according to some embodiments ofthe invention.

FIGS. 15A-C illustrate an embodiment of the ALTC system, a distalportion of the ALTC System and a proximal portion of the ALTC Systemrespectively.

FIG. 16A illustrates another embodiment of the axial lengtheningthrombus capture device in the delivery configuration, according to someembodiments of the invention.

FIG. 16B illustrates the axial lengthening thrombus capture device inthe initial deployed configuration wherein the outer sheath is retractedto expanded the axial lengthen thrombus capture device. The loop iscoupled to the sleeve wherein it is coupled to the capture cathetershaft, according to some embodiments of the invention.

FIG. 16C illustrates the axial lengthening thrombus capture deviceretracting proximally and lengthening, according to some embodiments ofthe invention.

FIG. 16D illustrates the lengthening of the axial lengthening thrombuscapture device and in some cases at full deployment, according to someembodiments of the invention.

FIGS. 17A-D illustrate different configurations of the ALTC device,according to some embodiments of the invention.

FIGS. 18A-B illustrate an embodiment of a distal portion of theaxially-lengthening thrombus capture system with a cover elementradially outward of, and partially or completely circumscribing thecapture guide of the ALTC device, which can be in the shape of a ring asillustrated.

FIGS. 19A-C illustrates an embodiment of an axially-lengthening thrombuscapture system, configured to allow the guidewire to distally exit thesystem prior to exiting the luer port at the proximal end of the system.

FIG. 20A illustrates the expanding guide catheter system in the deliveryconfiguration, according to some embodiments of the invention.

FIG. 20B illustrates the expanding guide catheter system wherein thefunnel tip is in deployed position and the obturator is positioned inthe expanding guide catheter lumen, according to some embodiments of theinvention.

FIG. 20C illustrates the expanding guide catheter having a funnel tip,expanding distal segment and non-expanding proximal segment, accordingto some embodiments of the invention.

FIG. 20D illustrates an obturator, according to some embodiments of theinvention.

FIGS. 21A-C illustrate the expanding guide catheter system including theexpanding guide catheter, outer cover and obturator, according to someembodiments of the invention.

FIG. 21D illustrates an embodiment wherein a cover tip encapsulates thedistal end of the outer cover of the expanding guide catheter system,according to some embodiments of the invention. FIGS. 21E-F illustratean embodiment of a hemostasis valve for use within a hemostasis guidecatheter system.

FIG. 22 illustrates the outer sheath assembly of the capture device,according to some embodiments of the invention.

FIGS. 23 and 24 illustrate the distal end and proximal end of the outersheath assembly respectively.

FIG. 25 illustrates the capture catheter assembly, according to someembodiments of the invention.

FIG. 26 illustrates the proximal end of the capture catheter, accordingto some embodiments of the invention.

FIG. 27 illustrates an embodiment of a key cap feature to enable ananti-rotation of the hypotube pusher.

FIGS. 28 and 29 illustrates the suction catheter that can include afunnel tip, catheter shaft, and connector with seal, according to someembodiments of the invention.

FIG. 30 illustrates the distal end of the suction catheter indicatingthe funnel tip and catheter shaft, according to some embodiments of theinvention.

FIG. 31 illustrates the proximal end of the suction catheter indicatingthe connector with seal and ports for use with filter chamber and accessto flush catheter lumen, according to some embodiments of the invention.

FIGS. 32-41 illustrate different macerator designs and shapes, accordingto some embodiments of the invention.

FIG. 42 illustrates a filter collection chamber that can include aninflow port to connect to a syringe, an outflow port to connect to thesuction catheter, a plunger, a filter to filter blood clot or debris andretain in the chamber and a chamber to collect blood clot or debris,according to some embodiments of the invention.

FIG. 43 illustrates a blood clot lodging in the left side of pulmonarysystem, according to some embodiments of the invention.

FIGS. 44A and 44B illustrate blood clots residing in the left sidepulmonary system and the capture device respectively, according to someembodiments of the invention.

FIG. 45 illustrates the initial deployment configuration of the axiallengthening thrombus capture device positioned distal to the thrombusoccluded area and a funnel tip positioned proximal to the thrombusocclusion, according to some embodiments of the invention.

FIG. 46 illustrates the axial lengthening thrombus capture devicelengthening proximally to capture the thrombus, according to someembodiments of the invention.

FIG. 47 illustrates the axial lengthening thrombus capture devicecompletely capturing the thrombus, and a funnel tip is inside the axiallengthening thrombus capture device.

FIG. 48A illustrates the delivery configuration of the capture catheterdevice, according to some embodiments of the invention.

FIG. 48B illustrates the initial deployment position of the axiallengthening thrombus capture device, according to some embodiments ofthe invention.

FIG. 48C illustrates the lengthening of the axial lengthening thrombuscapture device, according to some embodiments of the invention.

FIG. 48D illustrate the final deployment of the axial lengtheningthrombus capture device, according to some embodiments of the invention.

FIGS. 49A and 49B illustrate another embodiment of the axial lengtheningthrombus capture device wherein the guidewire lumen and capture catheteris offset to the longitudinal axis of the axial lengthening thrombuscapture device, according to some embodiments of the invention.

FIGS. 50A-50G illustrate an embodiment of the retrieval of thrombus intothe expanding guide catheter wherein the ALTC device lengthens distallyand creates additional space and the thrombus is redistributed andenable better retrieval into the expanding guide catheter. The funneltip and expanding section of the expanding guide catheter alsofacilitate the ease of thrombus retrieval.

FIG. 51 illustrates an embodiment of a system for removing blood clots.

FIG. 52 illustrates the distal end of the capture device of the systemof FIG. 51 in the deployed configuration.

FIG. 53 illustrates the distal end of the capture device of the systemof FIG. 51 in an initial deployed configuration.

FIG. 54 illustrates the distal end of the capture device of the systemof FIG. 51 in a second configuration.

FIG. 55 illustrates the distal end of the capture device of the systemof FIG. 51 in a third configuration.

FIG. 56 illustrates an embodiment of the basket mesh element of thesystem of FIG. 51. The basket mesh element can made of metallicmaterials such as Nitinol. The mesh element can be braided or laser cut.

FIG. 57 illustrates an embodiment of a capture device element of thesystem of FIG. 51.

FIGS. 58A-58B illustrate embodiments of an expandable loop element ofthe system of FIG. 51.

FIG. 59 illustrates a view of a capture device opening for a system forneuro thrombus.

FIG. 60 illustrates another view of a capture device opening of FIG. 59.

FIG. 61 illustrates an embodiment of a system.

FIG. 62 illustrates a distal end of the capture device system of thesystem of FIG. 61.

FIG. 63 illustrates a proximal end of the system of FIG. 61.

FIG. 64 illustrates an anchor assembly of the system of FIG. 61.

FIG. 65 illustrates a side view of a distal end of the capture deviceand anchors of the system of FIG. 61.

FIG. 66 illustrates a top view of a distal end of the capture device andanchors of the system of FIG. 61.

FIG. 67 illustrates a front view of a distal end of the capture deviceof the system of FIG. 61.

FIG. 68A illustrates the capture device of the system of FIG. 61 in aninitial deployed configuration.

FIG. 68B illustrates the capture device and first anchor release of thesystem of FIG. 61 when the outer sheath retracts proximally.

FIG. 68C illustrates the capture device, first anchor, and second anchorrelease of the system of FIG. 61 when the outer sheath is retracted.

FIG. 68D illustrates the capture device, first anchor, second anchor,and third anchor release of the system of FIG. 61 when the outer sheathis retracted.

FIG. 69A illustrates the capture device of the system of FIG. 61 in aninitial deployed configuration and the anchors are fully released.

FIG. 69B illustrates the capture device of the system of FIG. 61lengthened proximally to encapsulate the first anchor.

FIG. 69C illustrates the capture device of the system of FIG. 61lengthened proximally to encapsulate the anchors.

FIGS. 70A and 70B illustrate views of an embodiment of a pusher locksystem.

FIGS. 71A-71D illustrate views of a pusher lock of the pusher locksystem of FIG. 70A.

FIG. 72 illustrates a method of assembly an ALTC device to a captureguide.

FIG. 73 illustrates an embodiment of an anchor.

FIG. 74 illustrates an embodiment of an anchor.

FIG. 75 illustrates a distal end of a capture device system includingthe anchor in a vessel of FIG. 73.

FIG. 76A illustrates the capture device of the system of FIG. 75 in aninitial deployed configuration and the anchor is fully expanded.

FIG. 76B illustrates the capture device of the system of FIG. 75lengthened proximally to encapsulate a portion of the anchor.

FIG. 76C illustrates the capture device of the system of FIG. 75lengthened proximally to encapsulate the anchor.

FIG. 77A illustrates the capture device of the system of FIG. 75 in aninitial deployed configuration and the anchor is fully expanded.

FIG. 77B illustrates the capture device of the system of FIG. 75lengthened proximally to encapsulate a portion of the anchor.

FIG. 77C illustrates the capture device of the system of FIG. 75lengthened proximally to encapsulate the anchor.

FIG. 78 illustrates a distal end of a capture device system including anembodiment of an anchor.

FIG. 79 illustrates a distal end of a capture device system including anembodiment of an anchor.

FIG. 80 illustrates the capture device system in a vessel of FIG. 79.

FIG. 81 illustrates a distal end of a capture device system including anembodiment of an anchor.

FIG. 82 illustrates a distal end of a capture device system including anembodiment of an anchor.

FIG. 83 illustrates the capture device system in a vessel of FIG. 82.

FIG. 84 illustrates a distal end of a capture device system including anembodiment of an anchor.

FIG. 85 illustrates a distal end of a capture device system including anembodiment of an anchor.

FIG. 86 illustrates the capture device system in a vessel of FIG. 85.

FIG. 87 illustrates a capture device system in a vessel.

FIGS. 88A-88R illustrate embodiments of an anchor.

FIG. 89 illustrates an embodiment of a system designed for removing ablood clot.

FIG. 90 illustrates a distal end of the system of FIG. 89.

FIG. 91 illustrates a distal end of a system including an embodiment ofan anchor.

FIG. 92 illustrates a distal end of a system including an embodiment ofan anchor.

FIG. 93 illustrates a distal end of a system including an embodiment ofan anchor.

FIG. 94 illustrates the capture device of the system of FIG. 93lengthened proximally to encapsulate the anchor.

FIG. 95 illustrates a distal end of a system including an embodiment ofan anchor.

FIGS. 96A-96B illustrate an embodiment of an expandable guide catheter.

DETAILED DESCRIPTION

The present invention provides, in some embodiments, systems and methodsthat can be delivered percutaneously in a body to retrieve and removalmaterials including blood clots, stones/calculi, and/or foreignmaterials in a body lumen, including a blood vessel, such as an arterialvessel or a venous vessel within the circulatory system. The presentinvention can, in some embodiments, also apply to nonvascular areas totreat, for example, gallstones, kidney stones, common bile duct stones,and the like.

Systems can be delivered percutaneously, via a cut-down approach, athoracoscopic approach, or via other approaches, for example, using acatheter system 35, of which a perspective view of an embodiment isshown in FIG. 1. FIG. 1 also illustrates examples of various possibleelements that can be included in a material capture system, according tosome embodiments of the invention. As illustrated in FIG. 1, included insome embodiments are any number of, such as one, two, or more of thefollowing components: a first tubular member, such as an outer sheath 1,a second tubular member, such as a capture catheter 12, a third tubularmember, such as a guidewire tube 6 an axial lengthening thrombus capturedevice 8, a suction catheter 2, and a filter collection chamber 5. Theouter sheath 1 can, in some embodiments, be an elongate tubular memberwith a central lumen therethrough, and have a proximal end 1000 and adistal end 1001. The distal end 1001 of the outer sheath 1 can beoperably connected to a capture device (e.g., tubular mesh 8), which canbe movably axially with respect to the outer sheath 1. In someembodiments, the outer sheath 1 has a relatively rigid proximal portionand a distal portion that is more flexible than the relatively rigidproximal portion, which can be advantageous to flexibly expand ifnecessary to accommodate the passage of large clots and/or othermaterials. The proximal end 1000 of the outer sheath 1 can connect to aproximal hub 1003 that may include any number of: the suction catheter2, capture catheter 12, guidewire tube 6, and filter collection chamber5. Non-limiting examples of other optional elements that can be includedin the system (not shown in FIG. 1) include a macerator tool (describedelsewhere herein) and a discrete expanding guide catheter (describedelsewhere herein. In some embodiments, the outer sheath 1 has a lumenconfigured to house the suction catheter 2, which in turn has a lumenconfigured to house the capture catheter 4, which in turn has a lumenconfigured to house the guidewire tube/guidewire lumen assembly 6 andthe axial lengthening thrombus capture device (ALTC device) 8, which inturn has a lumen configured to house a guidewire (not shown)therethrough. An ALTC device as defined herein can include anystructure, such as a net-like structure for example, configured tocapture materials within a body location and axially lengthen andshorten through a working range, with or without radially shortening inwidth or diameter throughout that working range depending on the desiredclinical result. In some embodiments, the outer sheath 1 has an innerdiameter configured to house the capture catheter 12 coaxially therein,and the capture catheter 12, which in turn has a lumen configured tohouse the guidewire tube 6 and the body of the ALTC device 8. The ALTCdevice 8 can in some embodiments including a mesh net-like structurewith a proximal-facing opening at one end that can be made of a shapememory metal or polymer, a non-shape memory metal such as stainlesssteel, or another non-shape memory fabric, embodiments of which aredescribed in detail elsewhere herein. In some embodiments, conventionalnet-like structures such as used in IVC and other embolic filters can beutilized with systems and methods herein. In some embodiments, athrombus capture device can be configured in some embodiments to axiallylengthen throughout a working range, with or without radially shorteningthe device throughout the working range.

FIG. 2 illustrates a close-up view of the proximal end 1000 of thethrombus capture systems of FIG. 1. Illustrated is outer sheath 1configured to, in some embodiments, house suction catheter 2therethrough. Also illustrated is the proximal end of the outer sheath 1which can terminate in a connector 17 and hemostasis seal 190, of whichanother tube, such as the suction catheter 2 (and/or capture catheter 4)can be inserted coaxially into. The proximal end of the suction catheter2 can also include a connector 3 having a seal, and a lumen of which thecapture catheter 12 can be inserted into. The capture catheter 4 canalso include a connector with a seal 18 at its proximal end. Theguidewire tube 6 with a lumen to house a guidewire therethrough can beconfigured to fit coaxially within the capture catheter shaft 12. Alsoillustrated is an optional filter collection chamber 5 with a lumenfluidly connected to a lumen of the suction catheter 2. A proximal hub17 is also illustrated, as well as a flush port 20. In some embodiments,suction is not required (and as such a suction catheter 2 is notincluded in the system), and the clot or other materials can be capturedeither mechanically, hydraulically and/or maceration via the ALTC device8.

FIG. 3 illustrates an axially-lengthening thrombus capture system 35 inthe initial deployment configuration with the ALTC device 8 radiallyexpanded, according to some embodiments of the invention. Alsoillustrated is nose tip 7 distal to the ALTC device 8. Relative axialmovement of the outer tube 1 with respect to capture catheter 4 canallow for transformation of a first end (e.g., an expanded proximal endwith a proximal-facing opening, or distal or laterally facing opening inother embodiments) of the ALTC device 8 from a radially compressed to aradially expanded configuration. In some embodiments, the proximal endopening of the ALTC device 8 includes a capture guide 11 that takes theform of, in some embodiments, a radially expandable shape memory partialor full ring-like annular structure that expands once free of thesidewall of the outer tube 1 along with a portion of the ALTC devicemesh 8 attached to the capture guide 11. In the illustratedconfiguration, however, a significant portion of the surface area and/orthe axial length of the mesh of the ALTC device remains in a compressedconfiguration within the lumen of the capture catheter 4, as the otherend of the ALTC device mesh 8 is still operably attached, such as fixedto the outer diameter sidewall of the guidewire catheter 6.

FIG. 4 illustrates a close up view of the distal end of the ALTCcatheter system 35 in the delivery configuration including the distalend 1001 of the outer sheath 1 and nose tip 7, which can be atraumaticand tapered as shown, according to some embodiments of the invention.

The ALTC Device 8 can function to retrieve and capture materials such asthromboemboli. The capture catheter 4 is shown, along with the ALTCDevice 8, capture catheter shaft body 12, pull wire 10, and thrombuscapture guide 11.

As illustrated in FIGS. 5-9 for example, a thrombus capture guide 11 canattach to a portion, such as an open end of the ALTC Device 8 and one,two, or more capture pull wires 10 where the capture pull wires arepositioned inside the side lumen of the suction catheter 2 or outside ofthe lumen in other embodiments, and extends proximally. The distal endof the capture pullwire 10 can be connected to the proximal end of theALTC device 8 at the capture guide 11 as illustrated. The capturepullwire 10 can extend proximally through the length of the outer sheath1, and the proximal end of the pullwire 10 can be pushed or pulled allowa user to control, such as adjust the axial length of the ALTC device 8,for example when axially elongating the ALTC device in a proximaldirection. In some embodiments, the capture pullwire 10 and the captureguide 11 are the only elements attached to the proximal end of the ALTCdevice 8. In some embodiments, the capture pullwire 10 and the captureguide 11 can be made into a single component such as a Loop. In someother embodiments, the capture guide and the proximal end of the ALTCdevice is sutured in place using silk or polymeric filaments such asUltra-High Molecular Weight polyethylene, Nylon, PET, PTFE. In someembodiments, the open end of the ALTC device is covered with a lowdurometer film or coating and is then folded over the capture guide 11and suture to secure the assembly. In another embodiment, the open endof the ALTC device 8, capture guide 11 and sutured assembly is coatedwith a low durometer polymeric materials. Another method to secure thewire ends is to apply polymeric fabric either on the outer or innersurface of the tubular structure and secure via suturing in place withsuture filaments. The fabric can be at least one piece initially wrappedeither on the inner or outer surface of the tubular structure and thenfolded over to the opposite side to secure and protect with wire ends.The two sides of the fabric can secured to the tubular structure usingsuture filament. Other means of securing the fabric to the tubularstructure such as thermal bonding, press, lamination, chemicals,mechanical securement, and lasers can be used in some embodiments. Theclosed end of the ALTC device can be attached to an outer surface of theguidewire tube 6, which in turn can be positioned within a lumen of thecapture catheter shaft 12. As such, axial elongation of the ALTC devicein a distal direction can be achieved by, for example, movement of theguidewire tube 6 and pullwire 10 distally with respect to the capturecatheter shaft 12. The axial elongation of the ALTC device in a proximaldirection can be achieved by, for example, movement of the capturepullwire and capture catheter shaft proximally. The Thrombus CaptureGuide 11 can be formed, for example, from metallic, shape memory, orother appropriate materials. In some embodiment, the thrombus captureguide 11 can include a loop configuration and be formed from nitinolshape memory wire of various geometries such as round, oval, elliptical,flat, and the like. The thrombus capture guide 11 can be formed ofdifferent shapes such as a circular loop, oval loop, z-shape, etc. Insome embodiment, the loop 11 can be shaped set either into coils,multiple full circles, full circle or partial circles where the ends ofthe wire formed into two legs. The partial circle can be from, forexample, 180 degrees to 359 degrees or 220 degrees to 359 degrees. Thelegs can be configured to be off-axis to the loop such that it can beright angle, acute or obtuse angle relative to the loop. It can bearcuate and form a partial or full ring as illustrated, and cancircumscribe or otherwise form an outer diameter, and define theproximal-most end of the ALTC Device 8. The thrombus capture guide 11can in some embodiments include a single loop or multiple loopspositioned along the length of the ALTC Device 8 and not necessarily bepresent or have the entire guide 11 at the proximal-facing end openingend of the ALTC device 8. In some embodiments, the thrombus captureguide 11 does not include a loop. The ALTC Device tubular structure canbe configured to be compressed and positioned within the CaptureCatheter Shaft 12 lumen during introduction into the vascular systemwhere the Capture Catheter Shaft 12 is configured to be positionedcoaxially within and extend through the tubular structure and thrombuscapture guide 11.

As illustrated in FIG. 5, the Axial Lengthening Thrombus Capture Device(ALTC Device) 8 can be in some embodiments a generally tubular net-likemesh structure that is collapsible, expandable and configured to axiallylengthen or shorten, such as within a working range, while maintainingor substantially maintaining its diameter within the working range toretrieve and capture foreign or otherwise unwanted materials within thebody, including the vascular system such as blood clots, thrombus and/orforeign materials.

As shown, for example, in FIG. 6, it can also be possible to lengthenthe ALTC Device 8 in an appropriate direction, such as distally, bypushing the capture catheter 12 relative to the guidewire shaft 6,thereby allowing additional reserve radially compressed length of thetubular mesh 8 to radially expand out of the confines of the lumen ofthe capture catheter 12 to axially lengthen the Thrombus Capture Device8 and maintain its constant or substantially constant diameter through aworking range. The other end of the ALTC device 8 at its radiallycompressed end can be fixed to the outer sidewall of the guidewire tube6. A combination technique of, for example, manipulating the CapturePull wire 10 attached to the Capture Catheter shaft 12 movement (FIG. 6)can position the ALTC device at a desired location within the bodylumen, and movement of the guidewire catheter 6 axially with respect tothe capture catheter shaft 12 will also axially lengthen or shorten theALTC Device 8 while maintaining its diameter through a working range.When the ALTC Device 8 is in the deployed (expanded) configuration, theALTC Device 8 can also be stretched beyond the working range to anextended axial length to reduce its diameter.

FIG. 7 illustrates the axial lengthening thrombus capture device 8 isfully deployed such that the attachment site 128 of the ALTC device 8 onthe guidewire lumen 6 outer diameter is distal to the distal end of thecapture catheter shaft 12 and the funnel tip 9 of the suction catheteris positioned within the ALTC, according to some embodiments of theinvention.

FIGS. 8 and 9 illustrate different views of the initial deploymentposition of the ALTC Device 8 and the funnel tip of the optional suctioncatheter 2, according to some embodiments of the invention.

FIG. 10 illustrates the partially deployed ALTC Device, according tosome embodiments of the invention, where the ALTC device 8 is axiallylengthened while maintaining its width normal to the axial direction.

FIG. 11 illustrates an ALTC device deployed configuration where thefunnel tip of the suction catheter is positioned inside the ALTC device,according to some embodiments of the invention.

As illustrated, a Guidewire Lumen Assembly 6 can include a nose tip 7,shaft, lumen, and a proximal connector and port where a guidewire can beinserted therethrough. The central lumen can have a distal opening insome embodiments The guidewire tube 6 can be used to navigate and trackover the guidewire in the vascular system. The guidewire tube 6 canextend coaxially within the lumen of the catheter shaft 12. A nose tip 7can form or otherwise connect to the distal end of the guidewire tube 66 shaft to aid tracking the system through the vascular system, and canbe atraumatic in some embodiments. The guidewire tube 6 can be made ofpolymeric materials such as, and not limited to Polyimide, Nylon,Polyurethane, Pebax, Polyethylene, PET, PTFE or ePTFE. The guidewiretube 6 can have, in some embodiments, radiopaque markers along itslength for use to indicate the location of the ALTC Device, initialdeployment, partial deployment, final deployment, the percent of lengthdeployed and/or any combination thereof.

FIG. 12 illustrates the Axial Lengthening Thrombus Capture (ALTC)assembly 8 without the outer sheath, capture catheter 4, or guidewirecatheter 6 present for clarity. As illustrated, end 800 withproximal-facing opening 802 of the ALTC device 8 is in the expanded(deployed) configuration and is fixed to the thrombus capture guide 11and capture pullwire 10, according to some embodiments of the invention.For purpose of illustration, a reserve portion of unexpanded mesh 81including end 804 is in a collapsed configuration and extends proximallytoward attachment site 128.

In some embodiments, the tubular mesh structure 8 can axially lengthenor shorten without reducing or substantially reducing its diameterthrough a working length/axial range because the radially expandedportion of the tubular mesh structure is subject to none or minimaltension as it elongates or shortens axially through that axial workingrange. Not to be limited by theory, this can be accomplished at least inpart because the tubular mesh structure can elongate axially throughoutthe working range by unrolling, everting, or otherwise expanding ortransforming a radially compressed reserve segment of tubular mesh, suchas unexpanded mesh 81. As such, an expanded “end” opposite the end ofthe radially expanded device with the capture guide and proximal endopening, such as dynamic fold point 88 of the radially expanded portionof the tubular mesh 8 may not be the absolute end of the tubular meshfixed to a tubular shaft at zone 128, but rather an intermediate dynamicfold point 88 that is not fixed at that point to a tubular shaft, and assuch not under any, or not substantially under any tension. The radiallycompressed reserve segment of tubular mesh 81 thus extends back in adifferent or the opposite direction (e.g., proximally in some cases) andends at the terminal fixation point to the tubular shaft (e.g., atlocation 128). If it has not exceeded the working length of the expandedtubular shaft, the distance between the dynamic fold point 88 and thedistal end of the entire catheter system (e.g., the nose tip) canincrease as the radially expanded portion of the tubular mesh 8lengthens, and the radially compressed reserve segment is used up.

Once the compressed reserve segment 81 of tubular mesh 8 is nearly orcompletely expanded to, or almost to its actual end at 128 and thetubular mesh 8 is axially elongated beyond its working length range,further axial elongation can start to exert significantly increasedtension on the fully axially expanded tubular mesh structure 8, causingit to assume a configuration in which it radially contracts as itfurther axially lengthens.

A tubular net-like structure with one open end as disclosed above andelsewhere herein can be highly advantageous as a relatively small axialsegment of the tubular mesh can be radially expanded and be fullyfunctional to capture emboli and/or other materials in tight workingenvironments, such as in obstructed body lumens with limited space tomaneuver distal to the treatment location of interest. If it is desiredthat a greater axial length of radially expanded tubular mesh isrequired, such as to capture a relatively long length thromboemboli, thecompressed reserve segment of tubular mesh can be unrolled, everted orotherwise expanded or transformed to a specific axial length as desired.Having a compressed reserve segment that can be stored along the lengthof the catheter system in a compact manner can be very advantageous inproviding a long effective capture length tubular mesh without requiringthe entire capture system to have a long fixed length as would berequired in conventional filters/nets, which can be fixed at both endsand thus are functional and fully radially expanded when the first endis spaced apart from the second end at a single specific axial distance.

As illustrated in FIG. 12, some or most of the axial length of the ALTCdevice, e.g., the tubular mesh structure 8 remains radially compressedas part of the reserve segment between the outer diameter of theguidewire catheter 6 and the inner diameter of the shaft 12 of thecapture catheter (distance between of which is length L12B), with theradially expanded portion of the tubular mesh structure 8 being definedalong the axial length between proximal end 800 with proximal-facingopening 802 and the dynamic fold point 88 (distance between of which islength L12A), the sum of L12A and L12B amounting to the absolute lengthof the tubular mesh 8. In this initial configuration, the length L12B ofthe radially compressed reserve segment 81 can be about, or at leastabout 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or more of theabsolute length of the tubular mesh 8.

FIG. 13 illustrates the axial lengthening thrombus capture device 35 inthe initial deployed configuration, according to some embodiments of theinvention, with the radially expanded segment of the mesh 8 between end800 and dynamic fold point 88 and the reserve compressed segment (notshown) extending axially proximally past end 800 to fixation point 128on the outer surface of the guidewire shaft (not shown). FIG. 14illustrates the thrombus capture element 15 of the ALTC device that caninclude a stent, braided, woven, laser cut, or other mesh such as anet-like structure, according to some embodiments of the invention. Thetubular mesh structure need not necessarily be porous, and can becovered by nonporous or other layers. The ALTC Device tubular meshstructure 8 can be made of any suitable polymeric materials such as butnot limited to polyethylene terephthalate (PET), polyethylene (PE)polypropylene (PP), nylon, silk, UHMWPE, PTFE, Kevlar, cotton, and/ormetallic materials including superelastic material, nitinol, stainlesssteel, cobalt-chromium-nickel-molybdenum-iron alloy, or cobalt-chromealloy, Chronichrome, or Elgiloy. The tubular structure can be braided,extruded, woven, knitted, laser cut, dip, film cast from a polymericand/or metallic flat sheet, metallic filaments, polymeric filament orfabric in some embodiments. The tubular structure can be film cast withlaser cut holes in some embodiments. The tubular structure can also bebraided from polymeric and/or metallic filaments or any combinationthereof. In some cases, the tubular structure can be made of nitinolwire mesh having multiple wire strands. Furthermore, the tubularstructure can include at least one wire strand made of high radiopaquematerial such as tantalum, platinum, gold or nitinol drawn filler tubewith a platinum core to enable viewing the tubular structure underfluoroscopy. In some embodiments, the tubular structure can include one,two, or more radiopaque markers. Depending of the diameter of the ALTCdevice, the number of wire strands can range from, for example, 1 to 576wire strands. The ALTC Device can have 2, 4, 144, 288, or another numberof wire strands in some embodiments. In some embodiment, the ALTC deviceis configured to have one wire strand. The wire strand diameter canrange from, for example, 0.0002″ up to 0.015″. In some embodiments, thewire strand diameter is about 0.001″. The tubular structure can beimpermeable in some sections, permeable in other sections and/or acombination thereof. The tubular structure can be non-coated, or coatedwith one, two, or more anti-thrombogenic agents such as heparin toprevent clotting, or other therapeutic agents. The tubular structure canalso be coated with a hydrophilic or hydrophobic agent. The tubularstructure can have different pore sizes to assist with capturing smallemboli or larger pore sizes to allow perfusion or blood flow. Thetubular structure can have uniform pore sizes through the entire lengthor a combination of different pore sizes along its entire length. Forexample, when utilized as a cerebral protection filter, the ALTC devicepore size can be sufficiently large to capture clinical relevant embolisize as small as, for example, about 200, 175, 150, 125, 100, 75, 50microns or less while maintaining perfusion or blood flow. Duringretrieval, the ALTC device 8 can be repositioned to a particular sectionof the tubular structure that has smaller pore size and retrieve theblood clots/thrombus. In some embodiments, the ALTC device can deployand enmesh within the blood clot to capture the blood clot in, forexample, the neurovascular system. During retrieval, the ALTC device canlengthen sufficiently beyond the captured thrombus to create aprotection filter distal to the captured thrombus. This can beclinically beneficial to prevent thrombus from dislodging duringretrieval and thereby prevent secondary stroke. The ALTC Device tubularstructure 8 proximal end can, in some embodiments, attach to theguidewire tube 6 outer surface, such as near attachment site 128. Insome embodiments the proximal end of the ALTC Device tubular structurecan be wrapped and sutured with polymeric filaments and encapsulatedwith low durometer polymeric material to fixably secure the wire ends tothe shaft, such as the guidewire lumen assembly. Other means ofattachment to secure the wire ends such as mechanically, thermally orchemically bonding the polymer to secure the wire ends can be used. Inanother embodiment, the ALTC Device proximal end can be fixed to theouter surface of the guidewire shaft using adhesive and is sandwichedbetween the outer surface of the guidewire shaft and cover tubes.

FIGS. 15A-C illustrate another embodiment of a clot capture system, adistal portion of the ALTC System and a proximal portion of the ALTCSystem respectively. FIG. 15A schematically illustrates the cathetersystem 35, while FIG. 15B shows the distal nose tip 7 operably connectedto the distal end of the guidewire shaft 6 that includes a lumen for aguidewire to pass therethrough. One end of the ALTC device 8 can befixably attached to the guidewire shaft 6 at one or more locations 128and the other end 800 that includes proximal or distal-facing opening802 is attached to capture guide 11, such as in the form of a loop 11,and it is movable axially distally and proximally via capture guide 11Loop can include, for example, one, two, or more linear segments thatextend proximally from the loop 11 onto the capture catheter shaft 12,which are in turn secured proximally to the capture catheter shaft 12 bya the sleeve 30. The sleeve 30 in some embodiments can be presentinstead of the pullwire(s) extending proximally all the way through thedevice. This can in some cases be advantageous ergonomically and allowfor more streamlined control at the proximal end for a user. The axiallyexpanded length of the tubular mesh 8 is shown extending from end 800 todynamic fold point 88, with the reserve length of compressed tubularmesh (not shown) running proximally along the outer sidewall of theguidewire shaft 6 to its end at fixation point 128. FIG. 15C illustratesan embodiment of the proximal end of the system, including one or moreflush ports 13, hub 55 of the outer sheath 1, hub 155 of the capturecatheter 12, and hypotube pusher 14, and proximal-most hub 15 with alumen configured to slide a guidewire therethrough. The hypotube pusher14 can in some embodiments be coextensive with, such as welded orotherwise attached to the third tubular member (e.g., the guidewire tube6), and when manipulated by an operator effect axial movement of theguidewire tube 6 in a proximal or distal direction. In some embodiments,there can be an integral guidewire tube 6 from the proximal most hub 15to the distal nose tip 7. The third tubular member 14 can be configuredto be placed within a lumen of a second tubular member (e.g., capturecatheter shaft 12), such as at its proximal end at hub 155. The secondtubular member can be configured to be placed within a lumen of a firsttubular member (e.g., outer sheath 1), such as its proximal end at hub55. In some embodiments, hub 55 and hub 155 can include complementarythreads or other reversible locking features to allow for the outersheath 1 to be reversibly coupled to the capture catheter 12 to allowfor axial movement of the two tubular members in concert with eachother. Uncoupling the hubs 55, 155 can allow for axial movement of thecapture catheter 12 with respect to the outer sheath 1 and vice versa.

Still referring to FIGS. 15A-C, in some embodiments as illustrated, if asleeve 30 is present, no separate pullwire extends from the captureguide 11 proximally to the proximal end of the system. In some suchembodiments, axial movement of the capture catheter shaft 12 proximallywith respect to the guidewire tube shaft 6 facilitates radial expansionof at least a portion of the ALTC device 8 and positioning of the ALTCdevice 8 within a body lumen. Axial lengthening and/or shortening of theALTC device 8 in some embodiments can be effectuated by movement of theguidewire tube 6 (of which the other end of the ALTC device not attachedto the capture catheter 12 via sleeve 30 is attached to, such as atattachment site 128) with respect to the capture catheter 12 and/ormovement of the capture catheter 12 with respect to the guidewire tube6.

FIG. 16A illustrates another embodiment of a distal portion of the axiallengthening thrombus capture device 35 in the delivery configuration,according to some embodiments of the invention.

FIG. 16B illustrates the axial lengthening thrombus capture device inthe initial deployed configuration wherein the outer sheath 1 isretracted, e.g., proximally to radially expand an end that includes theproximal-facing opening 802 of the axial lengthen thrombus capturedevice (e.g., tubular mesh 8) to dynamic fold point 88 which serves asthe effective expanded distal end of the tubular mesh 8. The captureguide 11 and associated terminal wires 10 are operably coupled to thesleeve 30, and the sleeve 30 is coupled to the outer wall of the capturecatheter shaft 12, according to some embodiments of the invention. Thecompressed reserve length segment (not shown) of the tubular mesh, suchas about or at least about 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%or more of the absolute axial length of the ALTC device 8 (e.g., tubularmesh) taking into account folds remains inverted, rolled up, and/orotherwise radially compressed and circumscribed by the inner sidewall ofthe capture catheter shaft 12, up to the point where the other end ofthe ALTC device 8 is attached on an outer diameter of the guidewire tube6 at attachment site 128. As illustrated, the dynamic fold point 88varies along the length of the tubular mesh 8 depending on the length ofthe compressed reserve length segment that is expanded. The dynamic foldpoint 88 “floats” and is not directly attached to the guidewire shaft 6nor the capture catheter shaft 12, and as such moves axially proximallywhen the expanded segment of the tubular mesh 8 axially lengthens.

As such, when the guidewire shaft 6 with distal nose tip 7 is maintainedin a constant position, axial elongation of the expanded tubular mesh 8results in an increase in the axial distance D between the distal nosetip 7 and the dynamic fold point 88, so distance D3 is greater than D2,which is in turn greater than D1. Furthermore, as shown in FIG. 16B thefirst end 800 of the tubular mesh is distal to the unexpanded end of thetubular mesh (at location 128) fixed to the outer sidewall of theguidewire tube 6, but moves closer proximally in FIG. 16C and becomesproximal to the unexpanded end of the tubular mesh at FIG. 16D while thedynamic fold point 88 moves proximally but is still slightly distal tothe unexpanded distal end of the tubular mesh 8 in FIG. 16D, where theexpanded axial length is even greater, or in some cases at its maximumworking length. As noted, the diameter/width of the expanded tubularmesh remains constant or relatively constant between FIGS. 16A-D. Uponexhaustion of the compressed reserve segment which has transformed intoexpanded tubular mesh, continued axial expansion can result in increasedtensile forces on the tubular mesh, resulting in a configuration inwhich radial contraction begins to occur.

FIGS. 17A-D illustrate different configurations of the ALTC device,according to some embodiments of the invention. During delivery, thecapture guide 11 (e.g., ring-shaped in some embodiments) connected tothe expanded end 800 of the tubular mesh 8 can be configured to collapsewithin the outer sheath 1 lumen during introduction into the vascularsystem and is configured to radially expand first when the outer sheath1 retracts proximally while the length of reserve tubular mesh structure81 of the ALTC device 8 extending proximally from the dynamic fold point88 to fixation point 128 on the guidewire shaft 6 remains compressed inthe capture catheter shaft 12 lumen. The dynamic fold point 88 serves asthe effective expanded distal end of the tubular mesh 8. Upon furtherretracting the thrombus capture guide 11 via pulling the Capture PullWire 10 (or sleeve 30 as shown) and capture catheter shaft 12proximally, the portion of the ALTC Device 8 tubular structure that iscompressed within the Capture Catheter Shaft 12 lumen expands and cantransform via, e.g., roll out proximally, inversion, and/or eversion,and axially lengthening the ALTC Device 8. Advance of the CaptureCatheter Shaft 12 distally can collapse at least a portion of the ALTCDevice 8 tubular structure into the Capture Catheter Shaft 12 lumen, aspreviously shown in FIGS. 7-9. The ALTC Device's ability to expand, rollout, axially lengthen and maintaining a substantially constant diameterthrough a working range creates a cavity (or pocket) within the sidewallof the radially expanded segment of the ALTC Device 8 to retrieve andcapture foreign materials such as, for example, blood clots/thrombus. Inanother embodiment a sleeve 30 (FIGS. 16A-D and 17A-D) can be used tocouple, such as permanently, the Capture Pull Wire 10 to a portion ofthe Capture Catheter shaft 12 to enable both components to operatetogether. Coupling the Capture Pull Wire 10 and the Capture Cathetershaft 12 can allow the user to manage the capture device moreefficiently and easily. In another embodiment, the capture guide 11takes the form of a loop and can attach to the Sleeve 30, which iscoupled to the Capture Catheter Shaft 12.

FIGS. 18A-B illustrate an embodiment of a distal portion of theaxially-lengthening thrombus capture system with a cover element 80radially outward of, and partially or completely circumscribing thecapture catheter shaft 12 or loop 11 of the ALTC device, which can be inthe shape of a ring as illustrated. In some embodiments, the coverelement 80 can function to protect one or more of the capture guide,ALTC device, and the luminal wall of the lumen being treated. The ring80 can also be configured to provide a seal against the luminal wall,e.g., of the vessel, to prevent leakage or migration or embolization ofunwanted material around the tubular mesh 8. In some embodiments, thecover 80 can also include a skirt portion. The cover 80 can be axiallyand/or radially expandable, such as an inflatable balloon, a softpolymer, a gel, a foam, a textile fabric, shape memory, and/or includeother materials. If the cover 80 is expandable, it can be configured toreversibly contract to allow for fluid flow around the cover 80 once theprocedure is completed. Also as illustrated is sleeve 30 serving toattach the capture guide 11 connected to one or more wires 10. Sleeve 30can include one or more apertures 307 that serve as relativelyradiolucent markers, and/or the sleeve 30 could be made of a radiopaquematerial in some embodiments. Also as illustrated, the capture catheter12 as well as guidewire tube 6 can extend through the tubular mesh 6from first end 800 through dynamic fold point 88. The reserve segment ofcompressed tubular mesh is not shown for clarity.

FIGS. 19A-C illustrate an embodiment of an axially-lengthening thrombuscapture system, configured to allow the guidewire 350 to distally exitthe system prior to exiting the luer/proximal-most port 15 at theproximal end of the system. The guidewire's proximal end can exit thesystem through an aperture or slot 351 in the sidewall once it passesthe reversibly couplable hemostasis seals 55, 155 of the outer sheath 1assembly and the capture catheter 12 respectively. In some embodiments,the guidewire 350 is configured to exit sideways, that is laterally. Insome embodiments, a keyed cap 36 is positioned distal to the hemostasisseals 55, 155, which is in turn proximal to a shaft 14, which can serveas a hypotube pusher connected to or coextensive with the guidewire tubeand be made of metal in some embodiments. The shaft 34 can include asidewall groove 351 fully or partially axially from the port 15 to thehub 155 and/or one, two, or more discrete slots as illustrated.

Such embodiments can be advantageous, for example, to utilize a shorterlength guidewire needed when the delivery system overall lengthincreases. In some embodiments, when the ALTC capture device increase inlength, the hypotube is also lengthened to accommodate thus increase thedistance for user to manage the guidewire and system. The side guidewirefeature can minimize the distance resulting in better handling, and theproximal end of the guidewire 350 need not necessarily extend past theproximal end of the entire system, such as at port 15. As such, theguidewire as part of the system can advantageously have a total lengthin some embodiments that is the same as, or even less than the axiallength of the entire material capture system from proximal port 15 todistal nose tip 7, which may otherwise not be possible.

The guidewire 350 can be located near the hemostasis seals 55, 155 areaduring the procedure, and as such the entire procedure/operation can bedone with the user not needing to look down to see where the componentsare located. As such, the user can hold the hemostasis seals 55, 155housing in one hand while at the same time manipulating the guidewire350 and hypotube pusher 14 with the other hand in the general areawithout substantially moving away from the area. The users can hold andmaneuver the hypotube pusher 14 or hold and maneuver the guidewire 350or hold both the hypotube pusher 14 and guidewire 350 at the same time.In some embodiments, the inner diameter of the shaft 14 with groove canbe generally larger than the guidewire 350 that allows the guidewire 350to exit laterally. The keyed cap 36 with a boss profile can mate to thegroove of the metal shaft 14 to prevent the metal shaft 14 from rotatingand still allow the shaft 34 to slide back and forth axially.

In some embodiments, an Expanding Guide Catheter 50 (shown in FIGS.20-21 for example) is a discrete catheter that can be utilized togetherwith the clot capture system, and functions to assist in retrieving theALTC Device 8 (and associated catheter system 35) and capture bloodclots and other undesired materials. In some embodiments, the ExpandingGuide Catheter 50 can include a first tubular member, such as an outersheath 49 with a proximal end, a distal end, a lumen extending from theproximal end and the distal end, and a port on the proximal end, whichcan be coaxial as illustrated or offset from the longitudinal axis ofthe outer sheath 49. A second tubular member, such as inner catheter 54can have a proximal end, a distal end, and a lumen extending from theproximal end to the distal end and can be configured to be placed withinthe lumen of the outer sheath 49. The inner catheter 54 can also have aproximal port, a removable obturator 51 positionable in the innercatheter lumen, distal expandable funnel tip 52, expandable shaftsection 53 proximal to the funnel tip 52, an inner shaft 54, andconnectors with seal 55. The obturator 51 can be used to aid ininserting and navigating the Expanding Guide Catheter 50 in the vascularsystem. The obturator 51 can be made of polymeric materials such asPolyethylene, Nylon, Pebax, Polyurethane, PET or PTFE for example. Theobturator 51 can have a tapered distal end in some embodiments to aid inintroducing the Expanding Guide Catheter 50 in the vasculature or otherbody lumen. Alternatively, other embodiments of the obturator 51includes an expandable member such as a balloon operably connected tothe distal end. Expansion of the expandable member, such as inflatingthe balloon can create a smooth tip transition. The balloon can be madeof polymeric materials such Nylon, Polyurethane, PET, etc. Inflating theballoon can also secure the balloon obturator to the guide catheter suchthat when applying axial load proximally to the obturator shaft willarticulate the tip of guiding catheter. The funnel tip 52, illustratedfor example in FIGS. 20B-C, can include a distal funnel-like segment,and be adjacent to an expandable proximal segment 53 wherein it isconnected to a more proximal portion of the inner shaft 54. The funneltip 52 can be, in some embodiments, made of either polymeric and/ormetallic materials. It can be either tubular in shape, woven or braided.The braid configurations can be, in some cases, 1×1 or 1×2 or 2×1 or 2×2or any combination thereof. The picks per inch (PPI) can range from, insome embodiments, 5 to 60. The number can be, in some embodiments, fromone wire filament up to 288 wire filaments. The wire shape can be, e.g.,round, flat, oval, rectangular or square. The wire diameter can be,e.g., from 0.0005″ up to 0.015″. The flat wire thickness can be, e.g.,from 0.0005″ up to 0.010″ and the wire width can be, e.g., from 0.001″up to 0.030″. The funnel tip 52 distal segment can have various shapesor configurations to allow better retrieving the blood clots orthrombus. In some embodiments, the funnel tip 52 distal segment has alarge open end where it contacts the vessel wall when expanded andtransitions to smaller opening proximal segment 53. The distal segmentopen end can range from, in some embodiments, about 5 mm to about 80 mmin diameter. The funnel tip distal segment 52 also has, in someembodiments, openings or holes (perforations) along the side to allowblood flow. The funnel distal segment 52 can have either one layer ofbraid or multiple layers. In some embodiments, the funnel distal segmenthas two layers. In some one layer embodiments, the most distal open endof the funnel does not have the wire end terminate or exposed such thatthe wire ends are located at the proximal end of the funnel assembly.The funnel tip proximal segment 53 can be configured such that it iscapable of expanding and receive the ALTC device and captured bloodclots or thrombus. The proximal segment 53 can be configured to expandto receive object that is larger than its inner diameter and recoveryafter passage. The proximal segment 53 can include a PTFE inner layerand compliance and/or low durometer polymeric materials such asPolyurethane, Silicone, Tecoflex, Pebax 25D and/or 35D or braid and/ornon-braided such as Pebax/Propel/BaSO4 outer layer. The proximal segment53 can also include other lower durometer polymeric materials. Thecomposite funnel tip and proximal segment can be laminated via dippedcoat, spray or reflow process or any combination thereof. The braidmaterials can be either metallic and/or polymer and/or combinationthereof. The braid configurations can be, e.g., 1×1 or 1×2 or 2×1 or 2×2or any combination thereof. The picks per inch (PPI) can range from, forexample, 5 to 60. The number can be, e.g., from one wire filament up to288 wire filaments. The wire cross-sectional shape can be, for example,round, flat, oval, rectangular or square. The wire diameter can be,e.g., from 0.0005″ up to 0.015″. The flat wire thickness can be, e.g.,from 0.0005″ up to 0.010″ and the wire width can be, e.g., from 0.001″up to 0.030″. In some embodiments, an advantageous feature is theability to expand and contract without buckling under compression. Theinner diameter can range from, e.g., 2 F to 30 F. In some embodiments,the inner diameter can range from, e.g., 6 F to 18 F. The expandedlength section can be up to the entire catheter length. In someembodiments, the length is about 20 cm. The funnel distal 52 andproximal segment 53 can also be made as one component wherein the braidconfiguration is continuous. Coupled to or continuous with the funneltip proximal segment 53, the inner shaft 54 can be made from materialssuch as and not limited to Nylon, Polyurethane, Pebax, Polyethylene,PET, PTFE, or ePTFE. The inner shaft 54 can be braided or non-braided.The outer shaft 49 can function to slide over and collapses the funneltip and provide support during introduction into the vasculature. Theouter shaft 49 retracts to deploy the funnel tip. The outer shaft 49 canbe made of polymeric materials such as Nylon, Polyurethane, Pebax,Polyethylene, PET, PTFE, ePTFE, FEP or combination thereof. The outershaft 49 diameter can range from, e.g., 4 F to 34 F. The outer shaft 49inner diameter can range from, for example, 3 F to 32 F. In someembodiments, the inner diameter has substantially the same throughoutthe lumen shaft. In some embodiments, the inner diameter at the distalend is larger than the proximal end inner diameter. The change in innerdiameter can be in one location, two or more locations. The outerdiameter is substantially the same throughout the entire length of theouter sheath shaft. In some embodiments, the outer shaft 49 is about 22F or smaller in diameter. The outer shaft 49 can include a radiopaquemarker at the distal end or radiopaque filler along its shaft length forvisibility under fluoroscopy. In some embodiment, the outer shaft can bedeflectable (via, for example, one, two, or more pullwires on the distalend) at various locations and multiple deflectable directions along theshaft length to accommodate various tortuous paths such as entry intothe right atrium, right ventricle, main pulmonary artery, and left andright pulmonary artery for pulmonary embolism applications.

Still referring to FIGS. 20A-20D, in some embodiments the expandingguide catheter 50 can be utilized to retrieve blood clots or thrombus.The expanding guide catheter 50 and obturator 51 can be introduced overa wire into the vasculature and advanced near the treatment area. Theobturator 51 is removed. The outer member 49 of the expanding guidecatheter is retracted proximally to expand the funnel tip 52 and theexpandable section 53 of the guide catheter 50. In some embodiments, theguide outer shaft 49 is inserted into the vessel together with theobturator 51 and the obturator 51 is removed once the outer shaft 49 isin a desired position. The inner guide member can include the funnel tip52, proximal segment 53 and the inner shaft 54 is then inserted into theouter shaft 49 up to the distal tip of the outer shaft 49. The outershaft 49 can then be retracted (or the inner shaft 54 advanced) toexpand and deploy the distal funnel 52 and the proximal segment 53. Thecapture catheter system 35 is inserted over the wire and through thelumen of the expanding inner guide member 54. Once the ALTC Device 8 isdeployed and captures the blood clots, the ALTC Device 8 is retractedalong with the captured blood clots into the funnel tip 52 and expandingguide inner member 53, (shown later in FIG. 50). When high resistance isencountered at the funnel tip due to the large blood clot position atthe tip, the guidewire lumen can advances distally to lengthen the ALTCDevice. Lengthening the ALTC device can create additional space withinthe ALTC device such that the blood clot volume is redistributed therebyreduces the large blood clots pooled at the tip of expanding guidecatheter. The expanding guide catheter distal section also allows largerclots to be captured due to its expandability increasing the lumen size.Continuing to retract the ALTC device will retrieve additional capturedblood clots inside the expanding guide catheter. Repeated lengthening ofthe ALTC during the procedure will continue to redistribute the clot andretrieve inside the Expanding Guide Catheter, advantageously allowingfor improved thrombus processing and redistribution. In someembodiments, a kit can include a capture catheter system 35 as describedherein and configured to be reversibly placed within, and move axiallywith respect to an inner lumen of a discrete expanding guide cathetersystem 50 as described herein.

FIG. 21D illustrates an embodiment wherein a cover tip 710 encapsulatesthe distal end of the outer cover of the expanding guide cathetersystem, according to some embodiments of the invention. In someembodiments, a guide catheter is part of a hemostasis guide system thatcan includes one or more obturators, an inner shaft member, an outershaft member, and a hemostasis valve disposed within a housing of thesystem. The inner shaft member can include a non-expandable braidedproximal segment, a distal expandable segment and a braided funneldistal end which can be as described elsewhere herein. The inner shaftmember can be positioned within the lumen of the outer shaft member. Theouter shaft member can have, for example, a braided polymericconfiguration with a flexible kink resistance distal segment. The innershaft and outer shaft member can be attached to the housing body. Thehousing body can be, for example, at a proximal end of the guidecatheter system. The hemostasis valve can be disposed within the housingbody. The hemostasis valve can be in some embodiments a flexibledisc-like valve. The hemostasis valve can be configured to providehemostasis and prevent leakage, such as with nothing inside. In someembodiments, the system can be configured for use with a 0.035″guidewire, 5 Fr catheter, and include sizes between about 12 F and about17 F, such as about 12 F, 16 F, or 17 F. The hemostasis valve caninclude two surfaces, an upper surface and a lower surface. The uppersurface and lower surface can be opposing surfaces in some embodiments.The upper surface can include a slit extending partially across theupper surface and a depth into the valve without protruding all the waythrough the thickness of the lower surface. The lower surface caninclude a slit extending across the lower surface and a depth into thevalve without protruding all the way through the thickness of the uppersurface. In some embodiments, the valve has a diameter of between about0.50″ and about 1.00″, such as about 0.5″, 0.6″, 0.7″, 0.8″, 0.9″, or1.0″. In some embodiments, the valve has a thickness of between about0.050″ and about 0.0100″, such as about 0.075″. In some embodiments, theslits can have a depth/thickness of between about 0.020″ and about0.060″, such as about 0.040″. The midpoint of a slit can be in somecases at or proximate the center of the surface of the disc. The upperslit and the lower slits can intersect at, for example, a point locationwithin the valve. The slits can extend beyond the intersection point bya desired distance, such as between about 0.001″ and about 0.010″ orapproximately 0.005″ beyond the intersection point. In some embodiments,the arrangement of the slits along the valve permits insertion andremoval of shafts therethrough while preventing leakage of blood or airback across the valve. The upper and lower slits can have long axes thatintersect at an angle. The angle could be in some embodiments betweenabout 45 degrees and about 135 degrees, or about 45, 60, 75, or 90degrees in some cases.

FIGS. 22-24 illustrate the outer sheath assembly 1 of the capturedevice, according to some embodiments of the invention. The outer sheath1 can function to contain, protect, and deliver the Axial LengtheningThrombus Capture Device (tubular mesh 8 (not shown) to the desiredanatomical location, such as in a radially compressed configuration. Asshown in FIG. 22, the Outer Sheath 1 can include a soft atraumaticdistal tip, a shaft body that can be tubular in some embodiments, aninterior channel/lumen configured to house and reversibly couple at itsproximal end a second tubular member, such as a capture catheter asdescribed elsewhere herein, and a proximal connector with a seal 55 andflush tube/port 13. The Outer Sheath 1 can be made from suitable medicalgrade materials, including but not limited to Nylon, Polyurethane,Pebax, Polyethylene, PET, PTFE, ePTFE, PEEK, PEBAX/Propell andpolypropylene. The polymeric materials can include radiopaque materialssuch as, for example, barium sulfate, bismuth subcarbonate or bismuthtrioxide to enable viewing under fluoroscopy. The radiopaque materialscan form one, two, or more discrete marker elements in some embodiments,such as at the distal tip, and/or spaced apart at regular or irregularintervals along the length of the outer sheath 1. The outer diameter ofthe outer sheath 1 can range from, for example, 3 F to 30 F. The innerdiameter of the outer sheath 1 can range from, for example, 2 F to 28 F.In some embodiments, the inner diameter is substantially constantthroughout the interior channel, e.g., the lumen shaft. In someembodiments, the inner diameter at the distal end is about or at leastabout 10%, 20%, 30%, 40%, 50%, or more than the proximal end. The changein inner diameter can be, for example, stepwise or gradual in onelocation or two or more locations. The outer diameter can besubstantially the same the entire length of the catheter, in someembodiments. The outer sheath 1 working length can be, in some cases,from about 10 cm to about 150 cm. In some embodiment, the Outer Sheath 1working length is about 135 cm in some embodiments. The Outer Sheath 1shaft can be braided or non-braided. In some embodiments, the OuterSheath 1 shaft can be deflectable (via, for example, one, two, or morepullwires on the distal end) at various locations and multipledeflectable directions along the shaft length to accommodate varioustortuous paths such as entry into a left or right heart atrium, heartventricle, main pulmonary artery, and left and right pulmonary arteryfor pulmonary embolism applications, or a vein such as the greatsaphenous vein, superficial femoral, common femoral, SVC, IVC, or otherupper or lower extremity, visceral, or other superficial or deep veinsfor deep venous thrombosis removal applications. The distal end of theshaft of the outer sheath 1 can be configured to deflect up to 360degrees in some cases. Additionally, the distal tip of the Outer Sheath1 can be configured to deflect or bias toward or away from the vesselwall. The distal tip of the outer sheath 1 can include one, two, or moreradiopaque markers to indicate tip location. Alternatively, the distaltip can include radiopaque materials such as, for example, BariumSulfate, Bismuth Subcarbonate or Bismuth Trioxide. FIGS. 23 and 24illustrate the distal end and proximal end of the outer sheath assemblyrespectively. As shown in FIG. 26, the proximal end of the outer sheath1 connects to the outer sheath connector 55 with seal and coupler to acapture catheter connector, and flush port 13.

FIG. 25 illustrates the capture catheter assembly 12, according to someembodiments of the invention, showing catheter shaft 12 and outer sheath1. FIG. 26 illustrates the proximal end of the capture catheter,according to some embodiments of the invention, showing a connector withseal 155 operably connected to a flush port 13.

FIG. 27 illustrates an embodiment of a key cap 36 feature to prevent orinhibit rotation of the hypotube pusher 14. As illustrated, the key cap36 can be a tubular member with a lumen to fit the hypotube pusher 14therethrough. The lumen is non-circular in some embodiments, and/or havea non-circular zone, or otherwise configured to prevent or limitrotation. In some embodiments, the lumen includes teeth or otherprojections into the lumen as shown to prevent undesired rotation of thehypotube pusher. In some embodiments, the lumen or a portion thereof hasa square, rectangular, triangular, oval, pentagonal, hexagonal, or othernon-circular geometry, and configured to limit rotation.

In some embodiments, as illustrated in FIGS. 28-29 for example, anoptional suction catheter 2 can function to aspirate thrombus within theALTC Device 8. The suction catheter 2 can include in some embodiments adistal funnel tip 9, elongate shaft body 16, and proximal connector withseal 3. FIG. 30 illustrates a close-up view of the funnel tip 9 whichcan be attached at the suction catheter shaft 16 distal end to aid inretrieving the thrombus and allow efficient suction. The funnel tip 9can be made of, for example either polymeric and/or metallic materials.It can be tubular in shape, woven or braided, in some embodiments.Funnel tip 9 can be in various configurations to allow better retrievaland suction. In some embodiments, the funnel tip 9 has a funnel shapewith a first, larger distal diameter, a transition section, and asecond, smaller proximal diameter as illustrated. The suction cathetershaft 16 creates a pathway for the aspirated thrombus to travelproximally and exit the body and in some embodiments into the optionalfilter collection chamber. The shaft can be of various diameters,lengths and/or geometries to aid in the removal of materials such asblood clots. The suction catheter shaft can be made from suitablematerials such as and not limited to Nylon, Polyurethane, Pebax,Polyethylene, PET, PTFE, ePTFE, PEEK, and polypropylene. In someembodiments, the suction catheter Shaft distal end is expandable so toaccommodate large amount of blood clots. The suction catheter 2 canattach to the proximal end of filter collection chamber 5 to enablethrombus aspiration (or removal). In some embodiments, the suctioncatheter shaft 16 is deflectable at one, two, or more locations alongthe shaft length to accommodate various tortuous paths such as entryinto the right atrium, right ventricle, main pulmonary artery, and leftand right pulmonary artery. A proximal flush port 13 is alsoillustrated.

In some embodiments, a mechanical thrombectomy tool such as macerator 19shown in FIGS. 32-41 for example, can function to disrupt and break upthe thrombus within the ALTC Device 8. The macerator 20 can include adisruptor 19, shaft 22 and proximal connector with seal 21. AdjustableTouhy knob 23 distally is also shown just proximal to disruptor 19. Thedisruptor 19 can be attached to the distal end of the shaft 22. Themacerator 20 can have various end effector tip configurations asillustrated in FIGS. 35-41 depending on the desired clinical result tobreak up the thrombus within the ALTC Device 8, including a bulbousshape (FIG. 36), proximal and distal bulbs with a narrow waist (FIG.37), a plurality of proximal and distal bulbs with a narrow waist eachoffset by an angle, such as about 90 degrees (FIG. 38), a flower petaldesign with petals radiating radially outwardly from a central hub (FIG.39), a hemi-petal design (FIG. 40), or a substantially linear designorthogonal from the longitudinal axis of the shaft 22 (FIG. 41). Thedisruptor 19 collapses during insertion through the suction catheter 2system and expands once exiting the catheter. The disruptor 19 can bemade of, for example, metallic materials such as stainless steel,Nitinol, cobalt chrome, etc. The macerator can be activated either bymanual rotation, manipulation and/or a motorized handle.

To macerate the thrombus, the macerator 19 is inserted through thesuction catheter 2 and position within the ALTC Device 8. A manualtechnique applies to the luer connector 21 of the macerator 19 byrotating the luer connector 21 causing the disruptor 20 to rotatethereby breaking up the thrombus. Alternatively, the macerator 19 can beused with a motorized handle (not shown). Traversing the disruptor 20axially through the entire length of the ALTC device 8 can aid inbreaking up the thrombus.

The filter collection chamber 5 (FIG. 42) can function to suction andcollect the blood clots. The filter collection chamber 5 can include,for example, a collection chamber 325, filter 324, plunger 323, inflowport 327 and outflow port 326. The filter collection chamber 5 can havean outflow port 326 attaching to the suction catheter 2 connector and aninflow port 327 where a syringe or a similar device can attach foraspiration. The collection chamber 325 has a filter system 324 residinginside the chamber 325 to allow filtering the blood and thrombus. Thechamber 325 also has a plunger 323 for use in injecting fluid such assaline to fill the chamber 325 and push filtered blood back into thevasculature. The plunger 323 can serve as a seal on one side of thechamber.

To aspirate the thrombus from the system, the suction catheter 2 isattached to the filter collection chamber 5 (FIG. 42). A large syringeattaches to the proximal end of the filter collection chamber 5.Applying suction using the syringe causes the thrombus and blood clotsto migrate into the filter collection chamber 5. Once all the thrombusis contained within the chamber 5, close stopcock, detach the syringeand fill with saline and reattach the syringe to the filter collectionchamber 5. Alternatively, an extension tube and external saline filledsyringe can be used to fill saline into the suction syringe. Injectingvia the syringe will push saline into the chamber 325 causing theplunger 323 to push the blood back into the vasculature. The chamber 325will return the blood and leave the thrombus inside the chamber 325.Alternatively, the filter collection chamber 5 can be detached withoutreturning filtered blood to the system. Once the thrombus is removed,retract the suction catheter 2 inside the outer sheath 1. Retract theALTC Device 8 into the outer sheath 1 and remove the entire system fromthe body.

Catheter systems as described herein can be utilized for a variety ofindications depending on the desired clinical result. In someembodiments, the use is not limited to venous systems and can apply toother arterial, venous, or nonvascular areas such as neurovascular,peripheral vascular, cardiovascular, temporary embolic protection devicefor a cardiovascular procedure such as valve replacement, carotidprotection, pulmonary protection during deep vein thrombectomy orembolectomy), or retrieval of an implant, medical device, or othermaterial.

FIG. 43 illustrates a blood clot lodging in the left side of thepulmonary system. Shown is the right pulmonary artery 251, leftpulmonary artery 252, inferior vena cava 253, left iliac artery 254,right iliac artery 255, a pulmonary embolus 256 in the left pulmonaryartery 252 distally, and the superior vena cava 257.

FIGS. 44A and 44B illustrate blood clots residing in the left sidepulmonary system and the capture device respectively, according to someembodiments of the invention. In addition to the anatomical featuresillustrated in FIG. 43, also shown is the guide catheter 264, rightventricle 266, and right atrium 267. As shown in FIG. 44B, capturedevices as described and illustrated herein can advantageously beutilized when there is very limited distal space, as the device isfunctional throughout a wide working axial range as discussed elsewhereherein.

FIGS. 45-47 illustrate capture of a thrombus within a vessel, accordingto some embodiments. FIG. 45 illustrates the initial deployedconfiguration of the axial lengthening thrombus capture device (e.g.,tubular mesh) 8 with end 800, dynamic fold point 88, and reserveradially compressed segment (not shown) terminating proximally at point128 where the radially compressed segment is fixably attached to theouter sidewall of the guidewire lumen 6 is shown. The expanded segmentof the tubular mesh 8 is positioned distal to the thrombus 73 occludedarea and the expanding guide catheter 50 including distal funnel tip 52with proximal expandable section, inner catheter 54 and outer catheter49, or in some embodiments suction catheter funnel tip positionedproximal to the thrombus occlusion 73, according to some embodiments ofthe invention. In some embodiments, expanding guide catheter 50 asdescribed elsewhere herein or a suction catheter can be utilizeddepending on if suction is desired. Also shown proximally is innersheath 54 and outer sheath 49 of expanding guide catheter 50. Actuationof capture pullwire 10 alone or with capture catheter 12 such as axiallyin an appropriate direction (or capture catheter coupled to the outersheath (not shown) in embodiments with a sleeve as previously described)can result in axial lengthening or shortening of the ALTC device 8depending on the desired clinical result. FIG. 46 illustrates the axiallengthening tubular mesh 8 expandable segment lengthening proximally tocapture the thrombus, according to some embodiments of the invention,with the associated radially compressed segment shortening reciprocally.FIG. 47 illustrates the axial lengthening thrombus capture devicecompletely capturing the thrombus, and the expanding guide catheterfunnel tip or alternatively the suction catheter funnel tip is insidethe axial lengthening thrombus capture device. Subsequent suction viathe suction catheter 2 in embodiments where suction is utilized can beperformed to remove the blood clot or thrombus. The ALTC Device canlengthen to have a maximal length that covers the entire length ofcatheter system from, e.g., about 0.5 cm to about 125 cm. In someembodiments, the ALTC device may lengthen to about or at least about 2,3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 20, or more centimeters.Depending on vessel diameter, the outer diameter of the ALTC device canrange from, in some embodiments, about 1 millimeter up to about 80millimeters. For example, large vessels such as the inferior vena cava,superior vena cava, descending, and ascending aorta, the diameter canrange up to about 60, 70, 80, 90, 100 millimeters or more. Small vesselsin the neurovascular system can be, for example, as small as about orless than about 5, 4.5, 4, 4.5, 3, 2.5, 2, 1.5, 1, 0.5, or lessmillimeters in diameter. The diameter of the ALTC device can achieve thesimilar effect of reducing or stretching the ALTC device diameter. Insome embodiments, suction is not utilized or required, and the ALTCdevice envelops the clot, which can be mechanically pulled back into thecapture catheter. In some embodiments, the ALTC device can be utilizedto treat, for example, a clot in the carotid or cerebral arterial orvenous circulation. The vessels to be treated could include, forexample, the Circle of Willis, left or right common carotid or internalcarotid arteries, anterior cerebral arteries, anterior communicatingarteries, middle cerebral artery, posterior communicating arteries,carotid siphon, basilar arteries, vertebral arteries, or ophthalmicarteries for example, or any branches thereof. In some embodiments, theALTC device can be utilized to treat, for example, a femoral vein, abrachial vein, a pulmonary vein, a breast vein, a cerebral vein, a brainsinus vein, a renal vein, a portal vein, a jugular vein, or anothervein.

FIG. 48A illustrates another delivery configuration of the clot capturesystem 35 that can include features as previously described, accordingto some embodiments of the invention. FIG. 48B illustrates the initialdeployment position of the axial lengthening thrombus capture device,according to some embodiments of the invention, and reversible couplingof the hub 55 of the capture catheter 155 to the hub 55 of the outersheath. FIG. 48C illustrates the further lengthening of the expandedsegment of the axial lengthening thrombus capture device, according tosome embodiments of the invention, with reciprocal shortening of thereserve compressed segment 81. As illustrated, the guidewire tube 6 withnose tip 7 is maintained in position while the capture catheterreversibly coupled to the outer sheath can be withdrawn proximally. FIG.48D illustrate the final deployment of the axial lengthening thrombuscapture device at its maximal working length, according to someembodiments of the invention.

In some embodiments, systems and devices as disclosed herein can involvea general percutaneous technique, a cut-down procedure, or minimallyinvasive technique such as transapical, thoracoscopic, laparoscopic, orother techniques, for example, and not limited to transfemoral,transradial and/or internal jugular venous access. The technique canalso apply to the arterial system, including neurovascular,cardiovascular, and peripheral vascular applications, as well as for useas an embolic protection device such as for a cardiovascular proceduresuch as valve replacement or repair for example. In some embodiments, athrombectomy system can be delivered downstream of the aortic root, suchas prior to the aortic arch, and a variable-length shape memory meshstructure such as an ALTC device with an open proximal end and closeddistal end expanded prior to the index cardiovascular procedure, tocapture downstream emboli, calcifications, or other debris. In someembodiments, the system can be deployed to prevent embolization during adeep vein thrombectomy or pulmonary embolectomy, for example. In anotherembodiment, the system can be deployed to prevent embolization orretrieval during acute ischemic stroke. Systems and methods as disclosedherein can also be utilized in non-vascular anatomy such as the biliarytree to capture gallstones, common bile duct stones, and pancreatic ductstones, for example, in the ureters or bladder to capture kidney stones,or in the fallopian tubes to capture ova or other materials, or in thegastrointestinal tract such as the esophagus, stomach, duodenum,jejunum, ileum, or colon to capture, for example, foreign bodies.Described herein are some embodiments of using the venous system toaccess the pulmonary artery to treat pulmonary embolism. The techniquecan also apply to other areas of the vasculature. Initial puncture toaccess the femoral vein. A short access guidewire is inserted into thefemoral vein. Next, an appropriate 5 F or 6 F introducer sheath isinserted. The guidewire is exchanged for a 180 cm, 260 cm or 300 cmguidewire and advance pass the inferior vena cava, right atrium, rightventricle and the pulmonary artery to access the occluded treatmentarea. A longer length introducer/guiding catheter may be necessary tocross the tricuspid and pulmonary valve. Once the guidewire passesthrough the occluded treatment area, the 5 F or 6 F introducer sheath isexchanged for a long guiding catheter and position proximally near theoccluded area. The catheter system 35 is inserted over the wire andthrough the guiding catheter and advance distally to the occluded area.The catheter system 35 can also utilize the outer sheath deflectablefeatures to navigate through the vasculature without the use of aguiding catheter. Next, the catheter system's nose tip 7 passes throughthe occluded treatment area and positioned distal to the occludedtreatment area. The Outer Sheath 1 is retracted to deploy the thrombuscapture guide 11. The outer sheath 1 is retracted past the thrombus andpositioned proximal to the thrombus (occluded area). The SuctionCatheter 2 advances distally outside the Outer Sheath 1 and positionsproximally to the occluded area, if suction is utilized.

To retrieve and capture materials such as blood clots or thrombus, theThrombus Capture Guide 11 retracts by pulling the Capture Pullwire 10proximally while push/pull Capture Catheter 12 to axially lengthen theALTC Device 8 over the thrombus without substantially decreasing thedevice diameter. As needed, advancing the Capture Catheter shaft 12distally while pulling the Capture Pullwire will allow the ALTC Device 8to axially lengthen to capture the thrombus. Furthermore, the expandableFunnel Tip 9 of the Suction Catheter 2 (or the funnel tip of theexpanding guide catheter) can be positioned at the proximal end of theoccluded area to support and minimized thrombus movement. This maneuvercontinues until all thrombus is inside the ALTC Device 8. Once thethrombus is completely within the ALTC Device 8, pulling the ALTC Device8 away from the occluded area can restore immediate blood flow whilecontaining the thrombus inside the ALTC Device 8.

In some embodiments, the capture catheter shaft 12 and the guidewiretube 6 are configured to be positioned side-by-side adjacent (e.g.,offset and not coaxial, and not passing within the opening 802 or otherradially expanded portion of the tubular mesh 6) to the ALTC Device 8and capture guide (shown, for example, in FIGS. 49A and 49B). Alsoillustrated is the dynamic fold point 88, reserve radially compressedsegment 81 and compressed end at 128 fixed to the outer wall of theguidewire tube 6.

FIGS. 50A-50G illustrate the retrieval of thrombus into the expandingguide catheter wherein the ALTC device lengthens distally and createsadditional space and the thrombus is redistributed and enable betterretrieval into the expanding guide catheter. The funnel tip 52 andexpanding section 53 of the expanding guide catheter also facilitate theease of thrombus retrieval. For example, when the ALTC Device (e.g.,tubular mesh 8) captures the blood clot inside, the ALTC Device 8 canadvantageously stretch axially and compress radially beyond its workinglength (e.g., when the reserve radially compressed segment has beencompletely expanded, and/or by distal advance of the guidewire tube 6),effectively squeezing the blood clot radially to decrease itsdiameter/width. Fresh blood clots are typically soft and deformable.Applying axial stretching to the ALTC device can squeeze out the fluidthat is within the blood clot, thereby reducing the size of blood clotand allowing blood clots to be removed from the vascular system moreeasily. The ability of the ALTC Device to lengthen dynamically alsoprovides another clinically effective way to remove the large clotburden by redistributing the volume of blood clot or thrombus, as shown,for example, in FIG. 50A-50G. For example, with respect to currentinterventional devices such as filters and baskets, when blood clots orthrombus is collected and retrieved into a catheter such as a guidingcatheter or sheath, the blood clot or thrombus can gather together orpooled at base of the filter or basket into a large “ball-like” shapeand prevent the large “ball-like” thrombus to enter the lumen of theguiding catheter or sheath. A similar effect can occur whenaspiration/suction is attempted using a smaller inner diameter guidecatheter. However, the ALTC device can lengthen serially from the distalend to create additional length and space within the ALTC Device (asshown, for example, in FIGS. 50B, 50D, and 50F). By lengthening the ALTCDevice's distal end, the blood clot or thrombus is redistributed withinthe ALTC device thereby reducing the ball-like size of the blood clot,thrombus, or other material for better retrievable inside the guidingcatheter lumen (FIGS. 50C, 50E, 50G). These steps can be repeated forabout or at least about 2, 3, 4, 5, or more cycles until all the bloodclot and thrombus is retrieved in the catheter in a compacted form.Furthermore, the use of an expanding guide catheter with an expandabledistal section in concert with the ALTC device can allow more efficientblood clot or thrombus removal, as illustrated, for example, in FIGS.50A and 50C. The effectiveness of the ALTC Device 8 can be furtherdemonstrated in an extreme vascular condition where there is minimal tono distal space available for conventional thrombectomy catheters tofully axially expand in order to be functional. The distal space beyondthe distal end of the thrombectomy system can be in some cases less thanabout 3 cm, 2 cm, 1 cm, 5 mm, or less. In other words, the ALTC Device 8can be delivered in a first, radially compressed configuration, andcompressed by the outer sheath. Upon removal of the outer sheath, theALTC Device 8 can transform into a radially expanded configuration andconfigured to capture thromboemboli even though the device may be in anaxially compressed configuration. The ALTC Device 8 can then be axiallyexpanded, such as, for example, at least about 1.25×, 1.5×, 2×, 2.5×,3×, 3.5×, 4×, 4.5×, 5×, 5.5×, 6×, 6.5×, 7×, 8×, 9×, 10×, or more withrespect to its fully functional axially compressed length while stillmaintaining a constant or substantially constant radially expandeddiameter through a working range, such as between about 1 cm and about50 cm, between about 1 cm and about 20 cm, between about 1 cm and about10 cm, between about 1 cm and about 5 cm, or between about 1 cm andabout 3 cm in some embodiments. In some embodiments, the ALTC device 8has an open proximal end during delivery, and/or throughout its workingaxial length. The Thrombus Capture Guide 11 can advantageously deployinitially in the tight space while the ALTC device body remains insidethe Capture Catheter shaft 12. Subsequently, the Thrombus Capture Guideretracts proximally to begin deploying the ALTC Device 8. The potentialaxially expanded length of the ALTC Device 8 is not necessarily limitedand in some embodiments could extend to the entire length of thecatheter system. The ALTC Device 8 can be collapsed and contained withinthe Capture Catheter shaft 12 and Outer Sheath 1 during introductioninto the vasculature and expands when the Outer Sheath 1 retractsproximally to deploy the ALTC Device 8. The Capture Catheter shaft 12can be made from suitable materials such as and not limit to Nylon,Polyurethane, Pebax, Polyethylene, PET, PTFE, ePTFE, PEEK,polypropylene. It is also advantageous and possible in some embodimentsthat the Capture Catheter shaft 12 is deflectable at various locationsand multiple deflectable directions along the shaft length toaccommodate various tortuous paths such as entry into the right atrium,right ventricle, main pulmonary artery, left and right pulmonary arteryas previously described.

A perspective view of another embodiment of a capture system is shown inFIG. 51. FIG. 51 also illustrates non-limiting examples of variouspossible elements that can be included in a material capture system,according to some embodiments of the invention. As illustrated in FIG.51, included in some embodiments are any number of, such as one, two, ormore of the following components: a thrombus capturing device or ALTCdevice 201 having any of the features described herein, e.g., a pusherwire or inner pusher 202, a first tubular member such as an outer sheath203, a loop or capture guide 204, and a coupler 205. The ALTC device 201can attach to the capture guide 204. In some embodiments, the captureguide 204 comprises a metallic material, such as Nitinol. The captureguide 204 can be in the form of, for example, a loop, as shown, or anyclosed shape including an oval, ellipse, or polygon. The capture guide204 can be in the form of an open shape such as any linear or non-linearsegment. The ALTC device 201 and the capture guide 204 can be coupledsuch as being sutured together. The ALTC device 201 and the captureguide 204 can be encapsulated in a low durometer polymeric material. Thecapture guide 204 can be coupled to the outer sheath 203 via the coupler205. The proximal end of the ALTC device 201 (not shown) can be coupledto the inner pusher 202.

The outer sheath 203 can, in some embodiments, be an elongate tubularmember with a central lumen therethrough, and have a proximal end 2000and a distal end 2001, both shown in FIG. 51. The distal end 2001 of theouter sheath 203 can be operably connected to a capture device (e.g.,tubular mesh as described herein), which can be movably axially withrespect to the outer sheath 203. The proximal end 2000 can include anynumber of, such as one, two, or more of the following components: ahemostasis assembly 206, a flush port 207, and a collapsed segment 208.The outer sheath 203 extends proximally and can be coupled to thehemostasis assembly 206. The inner pusher 202 extends proximally and canbe coupled to a luer. In some embodiments, the inner pusher 202 can havea lumen to allow passage of a guidewire. In some embodiments, the innerpusher 202 is a solid shaft.

FIG. 52 shows the distal end 2001 of the ALTC device 201 in a deployedconfiguration. In some embodiments, the ALTC device 201 in the initialdeployed configuration has a low profile. A portion of the ALTC device201 is extended while the remaining length of the ALTC device 201 iscollapsed and contained within the outer sheath 203 as previouslydescribed. In some methods of use, the ALTC device 201 can be collapsedand tracked through a sheath or guide catheter (not shown) to theintended treatment area. In some embodiments, the guide catheter can beretracted proximally to initially deploy the ALTC device 201 and thecapture guide 204. For instance, the retraction of the guide cathetercan cause the capture guide 204 to expand. The capture guide 204 caninclude a compressed or constrained configuration while within the guidecatheter. During the initial deployment, the capture guide 204 isreleased from a constrained position to a neutral position. In theneutral position, the capture guide 204 creates a perimeter for the ALTCdevice 201. In the case of a loop or other circular configuration, thecapture guide 204 can create a constant diameter. In the case of othershapes or configurations, the capture guide 204 can create a constantcross-section. Alternatively or in combination, in other methods of use,the ALTC device 201 can be advanced distally from the guide catheter todeploy the ALTC device 201.

In some cases, only a small fractional portion of the ALTC device 201,such as less than about 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, 5%,or less of the axial length of the device can be initially deployed andfully functional. The small portion can correspond to an amount of theALTC device 201 which allows the capture guide 204 to assume the neutralposition. During the deployment of the capture guide 204, a length ofthe ALTC device 201 can be retained within the outer sheath 203. TheALTC device 201 can follow a curve from the capture guide 204 to theouter sheath 203. Retracting the outer sheath 203 can lengthen the ALTCdevice 201 while maintaining a constant diameter or cross-sectionprovided by the capture guide 204.

FIG. 53 illustrates an embodiment of an ALTC device 201 in the initiallydeployed configuration. As illustrated in FIG. 53, the ALTC device 201can be in some embodiments a generally tubular structure, and in somecases a net-like mesh structure that is collapsible within the outersheath 203. The ALTC device 201 is expandable to the diameter orcross-section provided by the capture guide 204. The ALTC device 201 canbe axially lengthened or shortened, such as within a working range, byreleasing the ALTC device 201 from the outer sheath 203. The ALTC device201 can be axially lengthened or shortened while maintaining orsubstantially maintaining the diameter or cross-section provided by thecapture guide 204. The ALTC device 201 can be deployed to form agenerally tubular or cylindrical shape of varying axial lengths. TheALTC device 201 can be axially lengthened or shortened to retrieve andcapture foreign or otherwise unwanted materials within the body,including the vascular system such as blood clots, thrombus and/orforeign materials. In some embodiments, an outer sheath is not presentand a loader can be utilized to prepare the ALTC device 201 for deliveryin a low crossing-profile configuration.

As shown, for example, in FIGS. 54 and 55, the ALTC device 201 can beaxially lengthened. FIG. 54 illustrates the ALTC device 201 in a secondconfiguration. The ALTC device 201 is in the second configurationwherein the deployed and expanded ALTC device 201 is longer than theinitial deployed configuration in the axial direction. The remainingcollapsed ALTC device 201 length resides inside the outer sheath 203 andis shorter than the initial deployed configuration. The outer sheath 203can be retracted to axially lengthen the ALTC device 201. As the outersheath 203 is retracted, the capture guide 204 is retracted since thecapture guide 204 is coupled to the outer sheath 203 via the coupler205. As the capture guide 204 is retracted, the ALTC device 201 isadvance from the collapsed portion 208 to the expanded portion. Theouter sheath 203 can be retracted proximally to axially lengthen theALTC device 201. Alternatively or in combination, in other methods ofuse, the capture guide 204 can be retracted to axially lengthen the ALTCdevice 201, such as be retracting the outer sheath 203. The diameter orcross-section of the ALTC device 201 can remain constant orsubstantially constant between the initial deployed configuration andthe second configuration.

Alternatively or in combination, in other methods of use, the innerpusher 202 is advanced distally to advance the proximal end of the ALTCdevice 201. As described herein, the proximal end of the ALTC device 201is coupled to the inner pusher 202. In the second configuration, theinner pusher 202 is advanced distally to release a portion of ALTCdevice 201 from the outer sheath 203.

FIG. 55 illustrates an embodiment of an ALTC device 201 in a thirdconfiguration. The ALTC device 201 is in the third configuration whereinthe deployed and expanded ALTC device 201 is longer than the secondconfiguration in the axial direction. The remaining collapsed ALTCdevice 201 length resides inside the outer sheath 203 and is shorterthan the second configuration. The outer sheath 203 can be retractedproximally to axially lengthen the ALTC device 201. The diameter orcross-section of the ALTC device 201 can remain constant orsubstantially constant between the second configuration and the thirdconfiguration. Alternatively or in combination, in other methods of use,in the third configuration, the inner pusher 202 is advanced distally toa greater extent. In the third configuration, the inner pusher 202 isadvanced distally to release a longer portion of ALTC device 201 fromthe outer sheath 203.

FIG. 56 illustrates an embodiment of the material capture, e.g., basketmesh element 209. The basket mesh element 209 can be a component of theALTC device 201. The basket mesh element 209 can be a structural meshthat provides an appropriate shape as described herein. The basket meshelement 209 can comprise Nitinol or other materials. The basket elementcan be braided, weave, wireform or laser cut. The basket mesh element209 can include a first end that couples to the capture guide 204. Thebasket mesh element 209 can be coupled to the capture guide 204 via asuture or other mechanical means including welding, clips, flanges,adhesive, lamination, etc. The basket mesh element 209 and the captureguide 204 can be encapsulated within a low durometer polymeric material.The second end of the basket mesh element 209 can be coupled to theinner pusher 202. The second end can be folded inward to couple to theinner pusher 202. The second end can be inverted to couple to the innerpusher 202. The second end 202 can form a tube within a tubeconfiguration of the ALTC device 201.

FIG. 57 illustrates an embodiment of the ALTC device 201. The ALTCdevice 201 has an expanded portion when the ALTC device 201 is deployed(e.g., initial deployed configuration, second configuration, thirdconfiguration, etc.). The expanded portion has a constant diameter orcross-section as described herein. The expanded portion, or a portionthereof, is coupled to the capture guide 204. The expanded portion iscoupled to the outer sheath 203 via the capture guide 204 and thecoupler 205. The ALTC device 201 has a collapsed portion 208. Thecollapsed portion 208 can reside within the lumen of the outer sheath203. The collapsed portion 208 can be retained within the outer sheath203 when the expanded portion is in the deployed configuration. Thecollapsed portion 208, or a portion thereof, can be coupled to the innerpusher 202. The collapsed portion 208 is everted as shown. During axiallengthening of the ALTC device 201, a portion of the collapsed portion208 can roll-out at a distal region to transition between the collapsedportion 208 and the expanded portion.

FIGS. 58A and 58B illustrate embodiments of the capture guide 204. FIG.58A illustrates the capture guide 204. FIG. 58B illustrates the captureguide 244, which can include any of the features of capture guide 204.The capture guide 204 can form a continuous shape. The capture guide 204can include leg elements 210. The leg elements 210 can transition thecapture guide 204 from an axial direction to a perimeter shape. Theperimeter shape can be circular as shown in FIG. 58A. The capture guide204 can form a continuous loop. The capture guide 244 can include anon-continuous perimeter. As shown in FIG. 58B, the capture guide 244can include a non-continuous loop. The capture guide 204, 244 can bemade of a metallic material. In some embodiments, the capture guide 204,244 is formed of a shape-memory material. In some embodiments, thecapture guide 204, 244 is formed from Nitinol. The capture guide 204,244 can be formed of a spring-like material such as a metal. The captureguide 204, 244 can be circular, elliptical, semi-circular, or anycombination thereof. The capture guide 204, 244 can include a pre-shapedcurve. The pre-shaped curve can be formed during the manufacturing ofthe capture guide 204, 244. The pre-shaped curve can be a neutral orexpanded shape of the capture guide 204, 244. Upon release of aconstraint, the capture guide 204, 244 will assume the pre-shaped curve.The capture guide 204, 244 can have any curved shape. The capture guide204, 244 can have a single radius of curvature or multiple portionshaving different radii of curvature. The capture guide 204, 244 can beconsidered spring loaded based in part of the material and the shape ofthe capture guide 204, 244. In some embodiments, the anchors can includenon-continuous shapes, such as hooks with sharp or atraumatic segmentsor tips in some cases.

The capture guide 204, 244 can have two or more leg elements 210. Theleg elements 210 can be adjacent or adjoining within the guide catheterduring delivery. The leg elements 210 can be relatively parallel orside-by-side during delivery in the collapsed configuration. Thecollapsed leg elements 210 can define a different diameter orcross-section as compared to the fully expanded or neutral configurationof the capture guide 204, 244. In some embodiments, the collapsed legelements 210 enable the capture guide 204, 244 to have a smallerdiameter or cross-section while collapsed within the guide catheter. Forexample, when the capture guide 204, 244 is fully expanded, the circularportion of the capture guide 204, 244 defines a diameter. Fornon-circular capture guide 204, 244, the capture guide 204, 244 candefine a cross-section when fully expanded. Upon collapsing the legelements 210, the circular portion of the capture guide 204, 244 definesa diameter that is smaller than the previous expanded configuration. Thecapture guide 204 can comprise one segment as shown in FIG. 58A with twoends that form a continuous loop configuration. The capture guide 244can comprise multiple segments as shown in FIG. 58B and form anon-continuous loop.

During expansion, the leg elements 210 can bias the capture guide 204,244 outward to assume the neutral configuration of the capture guide204, 244. The leg elements 210 can be positioned at an angle relative toeach other in the neutral configuration of the capture guide 204, 244.The leg elements 210 can include one or more bends to facilitate foldingof the capture guide 204, 244. The one or more bends can enable thecapture guide 204, 244 to fold in a low profile configuration along thelongitudinal axis of the guide catheter.

FIG. 59 shows one aspect of the opening of the ALTC device 201. The endof the ALTC device 201, or a portion thereof, attaches to the captureguide 204. While the capture guide 204 is shown in FIG. 59, any captureguide or feature thereof can be coupled to the end of the ALTC device201. The end of the ALTC device 201 and the capture guide 204 form anassembly. The assembly can be encapsulated within a low durometerpolymeric material to form a polymeric coating or ring 245. Thepolymeric coating can encapsulate the assembly completely or a portionthereof. In the illustrated embodiment, the polymeric coatingencapsulates a portion of the end of the ALTC device 201 and the captureguide 204. The polymeric coating can encapsulate the rounded portion ofthe capture guide 204 having a constant or substantially constantdiameter. The polymeric coating can encapsulate the entire ALTC device201, or any portion thereof. The area where the polymeric coating isvoid/not present can allow for easy movement. For instance, the areabetween the leg elements can be void. The void area can facilitatecollapse of the capture guide 204. In some embodiments, the polymericcoating can be selectively applied. In some embodiments, the polymericcoating can form a ring or a portion of a ring. The polymeric coatingcan be applied to the outside of the material capture element, e.g.,basket mesh element 208. The polymeric coating can be applied to theinside of the basket mesh element 208. The polymeric coating can beapplied to the entire basket mesh element 208 to encapsulate the basketmesh element 208.

FIG. 60 shows one aspect of the opening of the ALTC device 201. The ALTCdevice 201 can include a central, longitudinal axis. The outer sheath203 can include a longitudinal axis. The inner pusher 202 can extendalong the longitudinal axis of the outer sheath 203. The central,longitudinal axis of the ALTC device 201 can be offset from thelongitudinal axis of the outer sheath 203. The central, longitudinalaxis of the ALTC device 201 can be offset from the longitudinal axis ofthe inner pusher 202. The capture guide 204 can define the offset. Forinstance, the central, longitudinal axis of the ALTC device 201 caninclude the central point of the circle created by the capture guide204. The central point of the capture guide 204 can be offset from theouter sheath 203. As described herein, the end of the ALTC device 201 iscoupled to the inner pusher 202. The ALTC device 201 axially lengthensby releasing a portion of the ALTC device 201 from the outer sheath 203.The ALTC device 201 that is released follows a portion of the innerpusher 202 as shown in FIG. 59. The released portion of the ALTC device201 curves outward and assumes the diameter of the capture guide 204.The ALTC device 201 can form an everted shape with a portion of the ALTCdevice 201 collapsed near the inner pusher 202 and a portion of the ALTCdevice 201 expanded to the diameter or cross-section of the captureguide 204. In some embodiments, the shape of the ALTC device 201 canresemble a tube within a tube. In some embodiments, the ALTC device 201can be considered telescoping.

A perspective view of another system is shown in FIG. 61. FIG. 62 showsthe proximal end of the system and FIG. 63 shows the distal end of thesystem. FIG. 64 shows a subassembly of the system. FIGS. 61-64 alsoillustrates non-limiting examples of various possible elements that canbe included in a material capture system, according to some embodimentsof the invention. As illustrated in FIG. 61, included in someembodiments are any number of, such as one, two, or more of thefollowing components: an anchor assembly 221, a corewire and basketassembly 222, an anchor and pusher assembly 223, a proximal catheterassembly 224, and a distal catheter assembly 225. The anchor assembly221 can include about or at least about one, two, three, four, five, ormore anchors 241 configured to secure a clot. The anchor and pusherassembly 223 includes one or more anchors 241 and the anchor pusher 240.The anchors can be coupled to the pusher as described herein. Thecorewire and basket assembly 222 can include a corewire 242 and the ALTCdevice 201. The proximal catheter assembly 224 can include a shaft withone, two, or more lumens, e.g., the dual lumen shaft 243. FIG. 61illustrates a dual lumen shaft 243 of the system. The dual lumen shaft243 can be attached to the hemostasis housing 206 described herein. Thedual lumen shaft 243 can be coupled to the capture guide 204 via thecoupling 205. The illustrated embodiment shows a dual lumen shaft, butother configurations are contemplated. In some embodiments, the shafthas a single lumen. In some embodiments, the shaft is a multi-lumenshaft. The shaft can have about or more than about one lumen, twolumens, three lumens, four lumens, five lumens, six lumens, sevenlumens, etc. In some embodiments, the anchor 241 is a single loop. Insome embodiments, the anchor 241 is a continuous loop. In someembodiments, the anchor 241 has a closed perimeter. In some embodiments,the anchor 241 has an open perimeter. In some embodiments, the anchor241 forms a circular shape. In some embodiments, the anchor 241 forms anoval. In some embodiments, the anchor 241 forms any round, closed shape.

FIG. 62 illustrates the proximal end of the system including thecorewire and basket assembly 222, the anchor and pusher assembly 223,and the proximal catheter assembly 224. The corewire and basket assembly222 and the anchor and pusher assembly 223 can reside in separate lumensof the dual lumen shaft 243. The system can include the corewire 242.The corewire 242 can include any of the features or function as theinner pusher 202. The corewire 242 can be coupled to a pusher lock 246.The anchor pusher 240 can extend through the pusher lock 246. The pusherlock 246 can be movable along the shaft of the anchor pusher 240. Insome embodiments, the pusher lock 246 can limit the expansion of theanchors 241. In some embodiments, the pusher lock 246 can provide atactile response when the anchors 241 are deployed by abutting theanchor and pusher assembly 223 with the pusher lock 246.

FIG. 63 illustrates the distal catheter assembly 225. The distalcatheter assembly 225 can include any of the features described herein.The distal catheter assembly 225 can include the ALTC device 201. Thedistal catheter assembly 225 can include the coupler 205 between theouter shaft 203 and the capture guide 204.

FIG. 64 illustrates the anchor assembly 221. The anchor assembly 221 cancomprise one or more anchors 241. The anchor assembly 221 can compriseabout or at least about one anchor, two anchors, three anchors, fouranchors, five anchors, six anchors, seven anchors, eight anchors, nineanchors, ten anchors, or more than ten anchors 241. The illustratedembodiment shows three anchors, but other configurations arecontemplated. The anchor assembly 221 can include the anchor pusher 240.The anchor pusher 240 can include an elongate member comprising a shaft.The anchor pusher 240 can be extended proximally within the dual lumenshaft 243. The anchor pusher 240, or a portion thereof, can passproximally through the proximal catheter assembly 224. The anchor pusher240, or a portion thereof, can pass proximally through the pusher lock246. The anchor pusher 240, or a portion thereof, can be connected tothe luer hub. The anchor assembly 221 can be contained in the dual lumenshaft 243. The one or more anchors 241 can be coupled at a distal end ofthe anchor pusher 240. The one or more anchors 241 can be one anchor ora plurality of anchors 241. The anchors can be connected to the anchorpusher 240 in series, and regularly or irregularly spaced apart. In someembodiment, the diameter of the anchor 241 when expanded is smaller thanthe diameter of the capture guide 204 when expanded. In some embodiment,the diameter of the anchor 241 when expanded is smaller than the ALTCdevice 201 when expanded. The anchor 241 can be designed to fit withinthe ALTC device 201 when the ALTC device 201 is expanded. In someembodiments, the anchors can form symmetric or asymmetric loop shapes tocircumscribe and stabilize a portion of the clot. In some embodiments,the anchors can be an mesh or braided element. In some embodiments, theanchor can be a balloon. In some embodiment, there can be a combinationof braided mesh and balloon. In some embodiments, the anchors 241 canhave a portion that extend radially outwardly from the elongate memberin which they are attached.

FIG. 65 illustrates a side view of the distal end of the ALTC device 201and the anchors 241. The anchors 241 can include or be similar to any ofthe features of capture guide 204, 244 described herein. Each anchor 241can form a continuous shape, or a discontinuous shape in otherembodiments. Each anchor 241 can include leg elements 228. The legelements 228 can transition the anchor 241 from an axial direction to aperimeter shape. The perimeter shape can be circular as shown in FIG.64. The anchor 241 can form a continuous loop. The anchor 241 caninclude a non-continuous perimeter such as a non-continuous loop. Theanchor 241 can be made of a metallic material. In some embodiments, theanchor 241 is formed of a shape-memory metal such as Nitinol. The anchor241 can be circular, elliptical, semi-circular, or any combinationthereof. Each anchor 241 can include a pre-shaped curve. Two or moreanchors 241 can have the same pre-shaped curve. Two or more anchors 241can have a different pre-shaped curve. The pre-shaped curve can beformed during the manufacturing of the anchors 241. The pre-shaped curvecan be a neutral or expanded shape of the anchors 241. Upon release of aconstraint, the anchors 241 can assume the pre-shaped curve. Thepre-shaped curve of the anchors 241 can be similar to the pre-shapedcurve of the capture guide 204. The anchors 241 can have a differentradius of curvature from the capture guide 204. As described herein, theanchors 241 can have a smaller diameter than the capture guide 204.Alternatively, the anchors can have the same or larger diameter than thecapture guide. In some embodiments, the anchors include barbed elementsto attach to a clot. In some embodiments, the anchors are atraumatic anddo not include any barbed or other sharp surfaces.

The anchor 241 can have two or more leg elements 228. The leg elements228 can be adjacent or adjoining within the guide catheter duringdelivery, and relatively parallel to the. The leg elements 228 can berelatively parallel or side-by-side during delivery in the collapsedconfiguration. The collapsed leg elements 228 can define a differentdiameter or cross-section as compared to the fully expanded or neutralconfiguration of the anchor 241. In some embodiments, the collapsed legelements 228 allow the anchor 241 to have a smaller diameter orcross-section while collapsed within the guide catheter. For example,when the anchor 241 is fully expanded, the circular portion of theanchor 241 defines a diameter. For non-circular anchors 241, the anchor241 can define a cross-section when fully expanded. Upon collapsing theleg elements, the circular portion of the anchor 241 defines a diameterthat is smaller than the previous expanded configuration. The anchor 241can comprise one segment as shown in FIG. 64 that forms a continuousloop configuration. The anchor 241 can comprise multiple segmentssimilar to capture guide 244 shown in FIG. 58B. The anchors 241 have aoutwardly curving shape relative to the two or more leg elements 228.

The anchor 241 can include an expanded position as shown in FIG. 65. Inthe case of a shape memory material the expanded position can be aneutral position of the material. The anchor 241 can be configured tofold or bend during delivery. The anchor 241 can assume a low-profileconfiguration during delivery. The expanded anchor 241 can have anyshape including round, circular, elliptical, etc. The anchors 241 expandto their preformed shape upon removal of a constraint, such as outersheath 203, delivery catheter, or other constraining structure.

The expanded position of an anchor 241 can be defined by angle theta θ.In some embodiments, the angle theta is measured from the leg element228 to the circular portion of the anchor 241. In some embodiments, theangle theta is measured from the horizontal to the vertical extension ofthe anchor 241. In some embodiments, the angle theta is measured fromthe dual lumen shaft 243 to the expanded portion of the anchor 241. Insome embodiments, the angle theta determines the vertical orsubstantially vertical orientation of the anchor 241. Each anchor 241 ofa plurality of anchors 241 can have the same angle theta. If the anchors241 are arranged in a series, the angle theta can be uniformly the same.Two or more anchors 241 can have the same angle theta, or angles thatare within about 30, 25, 20, 15, 10, 5, 4, 3, 2, 1, or less degrees ofeach other.

Each anchor 241 of a plurality of anchors 241 can have a different angletheta. Two or more anchors 241 can have the different angle theta. Ifthe anchors 241 are arranged in a series, the series of anchors 241 canalso have different variations in the angle theta. For example, thefirst anchor 241 can have a first angle theta such as about or at leastabout 45 degrees, such as between about 0 and 90 degrees, between about15 and 75 degrees, or between about 30 and 60 degrees in some cases. Thenext or immediately adjacent anchor 241 can have a second angle thetasuch as 135 degrees. The next or immediately adjacent anchor 241 canhave a third angle theta such as 45 degrees. The series can continue toalternate between 45 degrees and 135 degrees or other desired angles. Insome embodiments, the series of anchors can have different diameter.

In some embodiments, two or more anchors 241 can form a mirror image. Insome embodiments, two or more anchors 241, 241 can extend from the duallumen shaft 243 such that the circular portion of one anchor 241substantially projects onto the circular portion of the other anchor241. In some embodiments, two or more anchors 241 can be identical orsubstantially identical in orientation. In some embodiments, two or moreanchors 241 can be coaxial. In some embodiments, two or more anchors 241have different orientations relative to the dual lumen shaft 243. Insome embodiments, two or more anchors 241 are not coaxial. In someembodiments, a first anchor 241 has a first axis extending through thecircular portion of the first anchor 241 and the second anchor 241 has asecond axis extending through the circular portion of the second anchor241. In some embodiments, the first axis and the second axis can beskewed. In some embodiments, the first axis and the second axis areperpendicular. In some embodiments, the first axis and the second axisare parallel. In some embodiments, the first axis and the second axisare coaxial.

In some embodiments, the angle theta can range from 5 degrees to 175degrees. Examples of the angle theta include 5 degrees, 10 degrees, 15degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, 40 degrees, 45degrees, 50 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, 75degrees, 80 degrees, 85 degrees, 90 degrees, 95 degrees, 100 degrees,105 degrees, 110 degrees, 115 degrees, 120 degrees, 125 degrees, 130degrees, 135 degrees, 140 degrees, 145 degrees, 150 degrees, 155degrees, 160 degrees, 165 degrees, 170 degrees, 175 degrees, etc., andranges incorporating any two of the aforementioned values. Examples ofthe angle theta can be in the range of 0-20 degrees, 20-40 degrees,40-60 degrees, 60-80 degrees, 80-100 degrees, 100-120 degrees, 120-140degrees, 140-160 degrees, 160-180 degrees, etc. In some embodiments, theangle theta can be approximately 90 degrees. In such embodiment, theanchor 241 can be approximately vertical relative to the dual lumenshaft 243. In some embodiments, the angle theta can be approximately 45degrees. In such embodiment, the anchor 241 can form an acute anglerelative to the dual lumen shaft 243. In some embodiments, the angletheta can be approximately 135 degrees. In such embodiment, the anchor241 can form an obtuse angle relative to the dual lumen shaft 243.

The anchor and pusher assembly 223, or a portion thereof, can be movedwithin the dual lumen shaft 243. In some embodiments, the anchor andpusher assembly 223 can be moved coaxially within a lumen of the duallumen shaft 243. The anchor and pusher assembly 223 can be movedindependently from the corewire and basket assembly 222. In someembodiments, the anchor and pusher assembly 223 can be movedsimultaneously with the corewire and basket assembly 222. In someembodiments, the anchor and pusher assembly 223 can be advanced distallyor proximally relative to the dual lumen shaft 243. In some embodiments,the anchor and pusher assembly 223 does not impact the movement of theALTC device 201. The one or more anchors 241 can be moved independentlyof the ALTC device 201. As described herein, the one or more anchors 241can be moved relative to a stationary ALTC device 201. As describedherein, the ALTC device 201 can be moved relative to a stationary anchor241.

FIG. 66 illustrates a top view of the distal end of the ALTC device 201and the anchors 241. The one or more anchors 241 can be coupled to adistal pusher 226. In some embodiments, the leg extensions 228 of theanchors 241 are coupled to the distal pusher 226. In some embodiments,the angle theta is measured from the distal pusher 226 to the expandedportion of the anchor 241. In the illustrated embodiment, each anchor241 is coupled to the distal pusher 226. The movement of the distalpusher 226 causes simultaneous movement of all anchors 241 coupledthereto. In alternative embodiments, two or more distal pushers 226 areprovided. Each of the two or more distal pushers 226 controls themovement of one or more anchors 241. The two or more distal pushers 226can move independently such that two or more anchors 241 can moveindependently. Other configurations are contemplated. The distal pusher226 can be coupled to a crescent pusher 227. In some embodiments, thecrescent pusher 227 can provide rigidity to the distal pusher 226. Thedistal pusher 226 and the crescent pusher 227 can be affixed viawelding, adhesive, mechanical interference, etc.

FIG. 67 illustrates a front view of the distal end of the ALTC device201 and the anchors 241. The dual lumen shaft 243 is shown in crosssection. In some embodiments, the dual lumen shaft 243 provides a lumenfor the anchor and pusher assembly 223 and a lumen for the corewire andbasket assembly 222. The two lumens can be separated such that movementof one assembly does not impact the movement of the other assembly.Other configurations are contemplated.

The corewire and basket assembly 222 includes the corewire 242. Thecorewire 242 is shown disposed in one lumen of the dual lumen shaft 243.The corewire 242 can include any of the feature or functions of theinner pusher 202 described herein. The compressed basket or compressedALTC device 201 is disposed in the same lumen of the dual lumen shaft243 as the corewire 242. The compressed ALTC device 201 can have any ofthe features or function as the collapsed segment 208 described herein.The outer shaft of the dual lumen shaft 243 is shown.

The anchor and pusher assembly 223 can include the distal pusher 226 andthe crescent pusher 227 described herein. The crescent pusher 227 can becoupled to the anchor pusher 240, described herein. In some embodiments,the distal pusher 226, the crescent pusher 227, and the anchor pusher240 are integrally or monolithically formed. In some embodiments, thedistal pusher 226 is a portion of the anchor pusher 240. The crescentshape of the crescent pusher 227 may prevent rotation of the crescentpusher 227 within the dual lumen shaft 243. The crescent pusher 227 isshown a lumen of the dual lumen shaft 243.

The anchors 241 can be coupled to the anchor pusher 240, such thatmovement of the anchor pusher 240 causes movement of the one or moreanchors 241. The anchors 241 can be coupled to the distal pusher 226,such that movement of the distal pusher 226 causes movement of the oneor more anchors 241. In some embodiments, the anchors 241 can be weldedto the distal pusher 226. The anchors 241 are arranged such that theanchors 241 are coaxial along central longitudinal axis 230. As shown inthe illustrated embodiment, only one anchor is visible from the frontview due to the coaxial nature of the anchors 241.

The ALTC device 201 is expanded as shown in FIG. 67. The outer diameter232 of the anchor 241 can be smaller than the inner diameter 233 of thebasket or ALTC device 201 in order for the ALTC device 201 to capturethe anchors 241. The ALTC device 201 can capture one or more anchorsdepending on the axial length of the ALTC device 201. The axial lengthof the ALTC device 201 is adjustable based on the release of the ALTCdevice 201 from the dual lumen shaft 243. As a longer portion of theALTC device 201 is released, the ALTC device 201 axially lengthens. Asdescribed herein, the ALTC device 201 remains at a constant diameter orcross-section as the ALTC device 201 lengthens. The capture guide 204maintains the shape of the expanded ALTC device 201 as the ALTC device201 axially lengthens. The capture guide 204 is smaller in diameter thanthe outer diameter 232 of the anchor 241.

The capture guide 204 can function as a centering device to center thesystem within the vessel. The capture guide 204 can be a similardiameter or cross-sectional shape as the vessel. In some methods of use,the capture guide 204 is smaller than the diameter of the blood vesselwhen the capture guide 204 is expanded. In some methods of use, thecapture guide 204 is approximately equal to the diameter of the bloodvessel when the capture guide 204 is expanded. In some methods of use,the ALTC device 201 is smaller than the diameter of the blood vesselwhen the ALTC device 201 is expanded. In some methods of use, the ALTCdevice 201 is approximately equal to the diameter of the blood vesselwhen the ALTC device 201 is expanded. In some methods of use, the ALTCdevice 201 contacts the vessel wall of the blood vessel. In some methodsof use, the ALTC device 201 does not contact the vessel wall.

The capture guide 204 can include the central longitudinal axis 231. Insome embodiments, the dual lumen shaft 243 can be offset from thecentral longitudinal axis 231. In some embodiments, the dual lumen shaft243 can be coaxial with the central longitudinal axis 231 (not shown).The anchor 241 can include the central longitudinal axis 230. In someembodiments, the dual lumen shaft 243 can be offset from the centrallongitudinal axis 230. In some embodiments, the dual lumen shaft 243 canbe coaxial with the central longitudinal axis 230 (not shown). In someembodiments, the central longitudinal axis 230 of the anchor 241 can beoffset from the central longitudinal axis 231 of the capture guide 204.In some embodiments, the central longitudinal axis 230 of the anchor 241can be coaxial with the central longitudinal axis 231 of the captureguide 204 (not shown). In some embodiments, the dual lumen shaft 243 canbe positioned near an edge of the capture guide 203. Otherconfigurations are contemplated.

FIGS. 68A-69C illustrate capture of a clot within a vessel, according tosome embodiments. FIG. 68A illustrates the ALTC device 201 in theinitially deployed configuration. As illustrated in FIG. 68A, the ALTCdevice 201 can be in some embodiments a generally semi-spherical meshstructure when initially deployed. The mesh structure is initiallycollapsible within a guide catheter or outer sheath 203. The guidecatheter delivers the ALTC device 201 to the desired location within thebody of the patient. The capture guide 204 is released from theconstrained condition within the guide catheter or outer sheath 203. Thecapture guide 204 expands to have a cross-sectional shape. In someembodiments, the capture guide expands to a round or circular shape.

The ALTC device 201 is expandable to the diameter or cross-sectionprovided by the capture guide 204. In some methods of use the ALTCdevice 201 is expanded by removal of a constraint. The ALTC device 201can be released from a guide catheter. The guide catheter can beretracted to allow the capture guide 204 to expand. In some methods ofuse, the ALTC device 201 can be released from within the dual lumenshaft 243 by retraction of the dual lumen shaft. As described herein,one end portion of the ALTC device 201 is coupled to the capture guide204. The ALTC device 201 can include a tubular mesh with a distal end.The ALTC device 201 can include a dynamic fold point as described hereinsuch that the tubular mesh becomes everted upon release from the duallumen shaft 243. The ALTC device 201 can include a reserve radiallycompressed segment within the dual lumen shaft terminating proximally ata point coupled to the inner pusher 202. In some methods of use, theexpanded segment of the ALTC device 201 is positioned distal to theblood clot. The outer sheath 203 is positioned proximally, within, oradjacent to the blood clot.

FIG. 68B shows the ALTC device 201 in the initially deployedconfiguration. As described herein, the corewire and basket assembly andthe anchor and pusher assembly can be independently actuated. The firstanchor 241 can be released when the outer sheath 203 retractsproximally. The first anchor 241 can include a shape memory materialsuch that the first anchor 241 assumes an expanded configuration. Thefirst anchor 241 can expand such that the first anchor 241 is defined bythe angle theta. The first anchor 241 expands from a low profileconfiguration to an expanded configuration. The low profileconfiguration can enable the anchor 241 to reside within the outersheath 203 during delivery. In some additionally or alternative methodsof use, the first anchor 241 can be released when the anchor pusher 240advances distally.

The released anchor can be firmly secured to the clot. In some methodsof use, the first anchor 241 can become entangled in the clot. In somemethods of use, the first anchor 241 can reside against the clot. Insome methods of use, the first anchor 241 can be designed to push theclot. In some methods of use, the first anchor 241 can be designed toperform a sweeping motion through the clot. The sweeping motion can beover an arc of the angle theta, or a portion thereof. The sweepingmotion can break the clot, or a portion thereof.

FIG. 68C shows the ALTC device 201 in the initially deployedconfiguration. The second anchor 241 can be released when the outersheath 203 retracts proximally. In some methods of use, the secondanchor 241 can be released when the anchor pusher 240 advances distally.The second anchor 241 can include a shape memory material such that thesecond anchor 241 assumes an expanded configuration. The second anchor241 can expand such that the second anchor 241 is defined by the angletheta. As described herein, the first anchor 241 and the second anchor241 can have the same or different orientation for the angle theta.

FIG. 68D shows the ALTC device 201 in the initially deployedconfiguration. In some methods of use, the third anchor 241 can bereleased when the outer sheath 203 retracts proximally. In additional oralternative embodiments, the third anchor 241 can be released when theanchor pusher 240 is advanced distally. The third anchor 241 can includea shape memory material such that the third anchor assumes an expandedconfiguration. The third anchor 241 can expand such that the thirdanchor 241 is defined by the angle theta. As described herein, the firstanchor 241, the second anchor 241 and the third anchor 241 can have thesame or different orientation for the angle theta.

The first anchor 241, the second anchor 241 and the third anchor 241 canbe designed to be secured to the clot. The arrangement of the anchors241 can be designed to facilitate engagement with the clot. Forinstance, the number of anchors, the spacing of the anchors, thecross-section dimension of the anchors, the shape of the anchors, theorientation of the anchors relative to the anchor pusher, the angletheta, the shape of the leg extension, the rapidness of the shape memorymaterial to assume the neutral shape, the stiffness of the material, aswell as other factors can be optimized to facilitate engagement of theanchors 241 with the clot.

The ALTC device 201 and the anchors 241 can retract proximally to removethe clot. In some methods of use, the ALTC device 201 can catch embolior debris that dislodges during removal of the clot. In some methods ofuse, the ALTC device 201 is positioned downstream in a vessel to catchdebris. The curved distal end of the ALTC device 201 can function as anet. In some methods of use, the anchors 241 can disrupt the clot toenable easier removal of the clot. In some methods of use, the sweepingmotion of deploying the anchors 241 can break apart the clot.

FIGS. 69A-69C illustrates the axial lengthening sequence of the ALTCdevice 201, according to some embodiments. The dual lumen sheath 243 canbe retracted to axially lengthen the ALTC device 201. As the dual lumensheath 243 is retracted, the capture guide 204 is retracted since thecapture guide 204 is coupled to the dual lumen sheath 243 via thecoupler 205. As the capture guide 204 is retracted, the collapsedportion 208 becomes the expanded portion. The dual lumen sheath 243 canbe retracted proximally to axially lengthen the ALTC device 201.Alternatively or in combination, in other methods of use, the captureguide 204 can be retracted to axially lengthen the ALTC device 201, suchas be retracting the dual lumen sheath 243. The diameter orcross-section of the ALTC device 201 remains constant between theinitial deployed configuration shown in FIG. 69A and the expandedconfigurations shown in 69B and 69C. In additional or alternativemethods of use, the corewire 242 can be actuated to axially lengthen theALTC device 201. The corewire 242 can be positioned within the duallumen shaft 243. Actuation of the corewire 242 such as axially in theappropriate direction will release the constrained portion of the ALTCdevice 201. The movement of the corewire 242 can result in axiallengthening or shortening of the ALTC device 201.

FIG. 69A illustrates the system after deployment of the anchors 241. Insome methods of use, the anchors 241 are deployed before axiallengthening of the ALTC device 201. In some methods of use, one or moresteps of releasing an anchor and axially lengthening can occur in anyorder. In some methods of use, the first anchor is deployed and then theALTC device 201 is axially lengthened to cover the first anchor. In somemethods of use, the first and second anchors are deployed before theALTC device 201 is axially lengthened to cover the first anchor or thesecond anchor. In some methods of use, the first, second, and thirdanchors are deployed before the ALTC device 201 is axially lengthened tocover the first anchor, the second anchor, or the third anchor. In someembodiments, two or more steps can occur simultaneously. In some methodsof use, the first anchor is deployed and the ALTC device 201 is axiallylengthened to cover the first anchor simultaneously. In some methods ofuse, the first and second anchor are deployed and the ALTC device 201 isaxially lengthened to cover either the first anchor or the second anchorsimultaneously. In some methods of use, the first, second, and thirdanchors are deployed and the ALTC device 201 is axially lengthened tocover the first anchor, the second anchor, or the third anchorsimultaneously.

FIG. 69B illustrates the axial lengthening of the expanded portion ofthe ALTC device 201. The ALTC device 201 is lengthening proximally tocapture the clot secured by the first anchor 241. The compressed orconstrained segment of the ALTC device 201 is shortening within the duallumen shaft 243 reciprocally. The dual lumen sheath 243 can be retractedto axially lengthen the ALTC device 201, as described herein. The ALTCdevice 201 can encapsulate the first anchor 241. The first anchor 241can be sized to fit within the ALTC device 201 once the ALTC device 201is axially lengthened.

FIG. 69C illustrates the axial lengthening of the expanded portion ofthe ALTC device 201. The ALTC device 201 is lengthening proximally tocapture the clot secured by the first anchor 241, the second anchor 241,and the third anchor 241. The compressed or constrained segment of theALTC device 201 is shortening within the dual lumen shaft 243reciprocally. FIG. 69C illustrates the axial lengthening ALTC device 201is sufficient to completely capture the clot. The ALTC device 201 andthe anchors 241 can retract proximally to remove the clot.

The ALTC device 201 can be axially lengthened, such as within a workingrange, by releasing the ALTC device 201 from the sheath, which can haveone, two, or more lumens in the sheath 243. The ALTC device 201 can beaxially lengthened or shortened while maintaining or substantiallymaintaining the diameter or cross-section provided by the capture guide204. The ALTC device 201 can be axially lengthened or shortened toretrieve and capture foreign or otherwise unwanted materials within thebody, including the neurovascular system such as blood clots, thrombusand/or foreign materials.

The ALTC device 201 described herein can be sized to fit within a vesselof the neurovascular system, including any vessel noted elsewhereherein. As one example, the ALTC device 201 can be used to treatarteries, veins, and non-vascular lumens or regions. In someembodiments, the device can be configured to treat cerebral venous sinusthrombosis and cavernous sinus thrombosis. A thrombus, commonly called aclot, is the product of blood coagulation due to aggregated plateletsand red blood cells connected by a fibrin protein to block a bloodvessel. The thrombus can travel (embolize), such as propagating towardthe heart, lungs or other organs. The removal of thrombus can reduce therisk of a stroke, myocardial infarction, and/or pulmonary embolisms. TheALTC device 201 can lengthen to have a maximal length that covers theentire length of anchors 241, e.g., from about 0.01 mm to about 100 mm.Depending on vessel diameter, the outer diameter of the ALTC device 201can range from, in some embodiments, from about 0.01 millimeter up toabout 10 millimeters. The diameter of the ALTC device can achieve thesimilar effect of reducing or stretching the ALTC device diameter. Insome embodiments, suction is not utilized or required, and the ALTCdevice envelops the clot, which can be mechanically pulled back into thecapture catheter. In some embodiments, the mechanical thrombectomysystems and methods as disclosed herein can be used in combination with,and/or coated with a therapeutic agent such as, for example, one or moreanti-thrombotic or anti-platelet agents such as heparin, hirudin,warfarin, dabigatran, and/or enoxaparin; tPA, streptokinase, orurokinase, an anti-proliferative agent such as paclitaxel (Taxol),rapamycin (Sirolimus), zotarolimus, or tacrolimus; and the likedepending on the desired clinical result.

FIGS. 70A and 70B illustrate views of an embodiment of a pusher locksystem. The pusher lock system can be utilized with any of the systemdescribed herein. FIG. 70A also illustrates non-limiting examples ofvarious possible elements that can be included in a material capturesystem, according to some embodiments of the invention. As illustratedin FIG. 70A, included in some embodiments are any number of, such asone, two, or more of the following components: a hemostasis seal 260, apusher lock 261, and a pusher 262. The hemostasis seal 260 can include aplurality of seals at spaced apart locations in the pusher lock system.The hemostasis seal 260 can be similar to the seals shown in FIGS. 21Eand 21F. The pusher lock 261 can include any of the features of pusherlock 246 described herein. The pusher 262 can include any of thefeatures of the inner pusher 202. The pusher 262 can include any of thefeatures of the corewire 242 described herein. The pusher 262 caninclude any of the features of the anchor pusher 240 described herein.

Referring first to the system shown in FIGS. 70A-B, the pusher 262 caninclude any of the features of the inner pusher 202 described herein.The pusher 262 can extend from the proximal end to the distal end. Insome embodiments, the pusher extends from the nosetip of the catheter tothe proximal end. In some embodiments, the pusher 262 is a single shaft.In some embodiments, the pusher 262 comprises one or more subcomponents.The pusher 262 can include an inner guidewire lumen shaft extending fromthe distal end toward the proximal end. The pusher 262 can include apusher tube extending from the proximal end. The inner guidewire lumenshaft can be attached to a pusher tube to form a unitary structure.Other configurations are contemplated. The pusher 262 can comprise anymaterial suitable to axially lengthen the ALTC device 201, as describedherein. In some embodiments, the pusher 262 or a component thereof,comprises a metal such as stainless steel or titanium. In someembodiments, pusher tube can comprise stainless steel.

The pusher 262 can be positioned coaxially within a shaft. In someembodiments, the pusher 262 is placed within a middle shaft. Theguidewire lumen shaft and the pusher tube assembly are positionedcoaxially within the middle shaft. The pusher tube is extended beyondthe middle shaft. The pusher tube can slide coaxially with respect tothe middle shaft to either lengthen or shorten the ALTC device 201.During clinical use, if there is no locking mechanism for the pusher262, the user can inadvertently actuate the pusher tube or the middleshaft prematurely, which will deploy the ALTC device 201. The pusherlock 261 helps to secure the pusher tube to the middle shaft duringinsertion of the catheter. The pusher lock 261 can be unlocked afterunsheathing the ALTC device 201. The pusher lock 261 can be unlockedwhen the user is ready for lengthening the ALTC device 201.

In some alternative and additionally embodiments, the guidewire lumenshaft and the pusher tube assembly are positioned coaxially within theouter sheath 203. The pusher tube is extended beyond the outer sheath203. The pusher tube can slide coaxially with respect to the outersheath 203 to either lengthen or shorten the ALTC device 201. In someembodiments, the pusher tube extends beyond the outer sheath 203, asshown in FIG. 51. During clinical use, if there is no locking mechanismfor the pusher 252, the user can inadvertently actuate the pusher tubeor the outer sheath 203 prematurely, which will deploy the ALTC device201. The pusher lock 251 helps to secure the pusher tube to the outersheath 203 during insertion of the catheter. The pusher lock 261 can beunlocked after unsheathing the ALTC device 201. The pusher lock 261 canbe unlocked when the user is ready for lengthening the ALTC device 201.

Referring now to the system shown in FIG. 62, the pusher 262 can includeany of the features of the corewire 242 described herein. The pusher 262can include any of the features of the anchor pusher 240 describedherein. The pusher 262 can extend from the proximal end to the distalend. The pusher 262 can include an inner guidewire lumen shaft extendingfrom the distal end toward the proximal end. The pusher 262 can includea pusher tube extending from the proximal end. Other configurations arecontemplated.

The pusher 262 is positioned coaxially within a shaft. In someembodiments, the pusher 262 is placed within a middle shaft of the duallumen shaft 243. The guidewire lumen shaft and the pusher tube assemblyare positioned coaxially within the middle shaft. The pusher tube isextended beyond the middle shaft. The pusher tube can slide coaxiallywith respect to the middle shaft to either lengthen or shorten the ALTCdevice 201. During clinical use, if there is no locking mechanism forthe pusher 262, the user can inadvertently actuate the pusher tube orthe middle shaft of the dual lumen shaft 243 prematurely, which willdeploy the ALTC device 201. The pusher lock 261 helps to secure thepusher tube to the middle shaft during insertion of the catheter. Thepusher lock 261 can be unlocked after unsheathing the ALTC device 201.The pusher lock 261 can be unlocked when the user is ready forlengthening the ALTC device 201.

In some alternative or additional embodiments, the pusher 262 is placedwithin an upper shaft of the dual lumen shaft 243. The guidewire lumenshaft and the pusher tube assembly are positioned coaxially within theupper shaft. The pusher tube is extended beyond the upper shaft. Thepusher tube can slide coaxially with respect to the upper shaft todeploy the anchors 241. During clinical use, if there is no lockingmechanism for the pusher 262, the user can inadvertently actuate thepusher tube or the dual lumen shaft 243 prematurely, which will deploythe anchors 241. The pusher lock 261 helps to secure the pusher tube tothe dual lumen shaft 243 after during insertion of the catheter. Thepusher lock 261 can be unlocked after unsheathing the ALTC device 201.The pusher lock 261 can be unlocked after unsheathing the first anchor241. The pusher lock 261 can be unlocked when the user is ready todeploy the anchors 241.

The method can include one or more of the following steps in any order.The delivery catheter can be prepared. The delivery catheter can beprepared at the bedside of a patient. The delivery catheter can beprepared according to one or more instructions. In some methods of use,the pusher lock 261 can be locked in position. The pusher lock 261 canbe locked in position on the pusher 262. In some embodiments, the pusherlock 261 is locked in position by rotating the lock cap 263. In someembodiments, the pusher lock 261 can be locked by rotating clockwise. Insome embodiments, the pusher lock 261 can be locked by rotatingcounterclockwise.

In some methods of use, a guidewire is positioned within a patient. Insome methods of use, the inner guidewire lumen shaft of the pusher 262can be guided over the guidewire. In some methods of use, the pushertube of the pusher 262 can be guided over the guidewire. In some methodsof use, the system is advanced over the guidewire. In some methods ofuse, the delivery catheter is advanced to the intended area fortreatment. In some methods of use, the delivery catheter is retracted.In some methods of use, the outer sheath 203 is retracted to deploy theALTC device 201.

In some methods of use, the pusher lock 251 is unlocked. In some methodsof use, the pusher lock 261 is unlocked by rotating the lock cap 263counterclockwise. In some methods of use, the pusher lock 261 isunlocked by rotating the lock cap 263 in an opposite direction. Uponunlocking the pusher lock 261, the ALTC device 201 can be lengthened. Insome methods of use, the ALTC device is lengthened by axially actuatingthe middle shaft. In some methods of use, the ALTC device is lengthenedby axially actuating the pusher tube. In some methods of use, the ALTCdevice is lengthened by axially actuating the outer sheath. In somemethods of use, the ALTC device is lengthened by axially actuating thedual lumen shaft. The pusher lock 261 can be used to affix the pushertube to the middle shaft as needed.

FIGS. 71A-71D illustrate views of a pusher lock 261 of the pusher locksystem of FIG. 70A. As illustrated in FIG. 71A-71D, included in someembodiments are any number of, such as one, two, or more of thefollowing components: the lock cap 263, a collet 264, and a lock body265. The lock cap 263 and the lock body can include mating threads. Inthe illustrated embodiment, the lock cap 263 includes female threads andthe lock body 265 includes male threads. The collet 264 is disposedbetween the lock cap 263 and the lock body 265. The pusher 252, or aportion thereof, is designed to be placed within the collet 264. Thepusher 252 can extend through an opening in the lock cap 263, throughthe collet 264, and through an opening in the lock body 265. The lockcap 263 also includes a ramped surface designed to interact with thecollet. As the lock cap 262 is rotated, the collet 264 can be broughtinto engagement with the ramped surface. Further rotation can cause thecollet to collapse or tighten onto the pusher 252. Other configurationsare contemplated.

FIG. 72 illustrates a flow chart of an embodiment of a method 300. Insome embodiments, the method can assemble the end of the ALTC device 201to the capture guide 204. The method can include one or more of thefollowing steps, in any order. The step 301 can include mixing athermoplastic and/or polyurethane, e.g., Pellethane solution. Thesolution is mixed using, e.g., a thermoplastic polyurethane, e.g.,Pellethane and, e.g., a cyclic ester such as Tetrahydrofuran (THF). Themixture of Pellethane and Tetrahydrofuran (THF) ratio can range from,e.g., between about 1:1 and about 1:20 of Pellethane to THF. The ratioof Pellethane to Tetrahydrofuran can be, for example, about, at leastabout, or no more than about 1:1, 1:2, 1:3, 1:4, 1:5, 1:6, 1:7, 1:8,1:9, 1:10, 1:11, 1:12, 1:13, 1:14, 1:15, 1:16, 1:17, 1:18, 1.19; 1:20,or ranges including any two of the aforementioned values. The step 302can include trimming the ALTC device 201. The end of the ALTC device 201can be squared trim. The step 302 can include loading the ALTC device201 on the dipping mandrel. The dipping mandrel can be made of polymericand/or metallic materials such as HDPE, PTFE, stainless steel, etc. Themandrel can be non-coated or coated to allow ease of manufacturing. Thestep 303 can include dipping the ALTC device 201 in the solution. TheALTC device mounted on a dipping mandrel is slowly dipped into thePellethane/THF solution. The step 303 can include drying the ALTC device201. The ALTC device 201 can hang to allow to dry, or dried using othermechanisms. The step 304 can involve removing the ALTC device 201. Thestep 304 can involve trimming the excess Pellethane. The dipped end ofthe ALTC device 201 can encapsulate and fix the wire ends of the basketmesh element 209 from movement. The dipped end can prevent the wire endsof the basket mesh element 209 from being exposed. The ALTC device 201is removed from the dipping mandrel. The excess Pellethane is trimmedclose to the edge of the ALTC device 201.

The step 305 can include punching or otherwise creating one or moreapertures in the Pellethane coating. The dipped area of ALTC device 201can be punched to create holes at predetermine location to allowplacement of the capture guide. Other methods of making holes in thecoating are contemplated. The step 306 can include inserting the captureguide 204 into the punched hole. The capture guide 204 is inserted intothe punched hole. The capture guide 204 can be woven through two or moreholes. The capture guide can be threaded from one side of the ALTCdevice 201 to the other side of the ALTC device 201. The step 307 caninclude folding the edge of the ALTC device to cover the capture guide204. The dipped coat edge of the ALTC device 201 is folded to cover thewire loop of the capture guide 204. The folding can protect and preventthe encapsulated wire ends of the basket mesh element 209 fromprotruding. The step 308 can include suturing the ALTC device 201 andthe capture guide 204. The ALTC device 201 is sutured to the captureguide 204 using suture materials. Suture materials can include, forexample, PET, PTFE, HMWPE, or other materials known in the art. The step309 can include suturing around the edge of the ALTC device. The step309 can include suture the back stitch around the edge.

The step 310 can include loading the ALTC device onto the formingmandrel. When the suturing is completed, the ALTC device 201 in thenloaded onto the forming mandrel. The step 311 can include thermallyforming the stitched ALTC edge. The step 311 can include thermallyforming the stitched ALTC device edge using appropriate heating. Theforming mandrel can be either polymeric or metallic materials such asPTFE, stainless steel, etc. The step 312 can include dipping the ALTCdevice and capture device. The ALTC device and capture device can bedipped in the Pellethane solution from step 301. The ALTC device andcapture device can be dipped in another solution. The dipping processcan include dipping the ALTC device 201 and capture guide 204 into thePellethane/THF solution. The dipping can secure the assembly of the ALTCdevice 201 and capture device 204. The step 312 can include loading theassembly of the ALTC device 201 and capture device 204 onto the dippingmandrel. The dipping mandrel can be the same dipping mandrel of steps302, 303. The dipping mandrel can be a different mandrel. The dippingmandrel for this step 312 can be made of polymeric and/or metallicmaterials such as HDPE, PTFE, stainless steel, etc. The mandrel for thisstep 312 can be non-coated or coated to allow ease of manufacturing. Insome methods of use, a film or sheet of material can be used in additionor in place of one or more dipping steps. The film can be an extrudedpolymeric film. The sheet can be a sheet of low durometer polymer suchas pellethane, polyurethane, tecothane, etc. The film or sheet can beused and place over the end of the ALTC device. In some methods of use,a film or sheet of material can be used in addition thermally formingthe edge of the ALTC device 201. The film or sheet can be thermallyfused. The film or sheet can be laminated together. Other manufacturingmethods are contemplated.

FIGS. 73-94 illustrate embodiments of anchors. The anchors describedherein can be used in conjunction with, or in place of, anchors 241. Theone or more anchors described herein can form an anchor assembly 221described herein. The anchor assembly 221 can include about or at leastabout one, two, three, four, five, or more anchors configured to securea clot. In some embodiments, two or more anchors of the anchor assembly221 can be the same. In some embodiments, two or more anchors of theanchor assembly 221 can be different. In some embodiments, two or moreanchors of the anchor assembly 221 can be selected from anchorsdescribed herein. In some embodiment, the diameter of the anchor whenexpanded is smaller than the ALTC device 201 when expanded. In someembodiment, the anchor can be designed to fit within the ALTC device 201when the ALTC device 201 is expanded. In some embodiments, the anchorcan be designed to substantially the same or larger than the ALTC device201. In some embodiments, the distal end of the ALTC device 201 has aflexible, atraumatic extension forming the distal end of the system. Insome embodiments, the distal end of the ALTC device 201 has an anchor.In some embodiments, the anchor can have any shape to entangle a portionof the clot. In some embodiments, the anchor can have any shape tostabilize a portion of the clot. In some embodiments, the anchor canhave any shape to provide radial support to the clot. In someembodiments, the anchor can have any shape to provide axial support tothe clot. In some embodiments, the anchor can have any shape to move aportion of the clot, such as distally toward the ALTC device 201 orproximally away from the ALTC device 201. In some embodiments, theanchor can rotate. In some embodiments, the anchor can move axial tobreak up the clot.

The systems described herein can include the guidewire lumen 6, whichcan advance distally to lengthen the ALTC device 201. Referring to FIG.5, the outer sheath 1 has an inner diameter configured to house thecapture catheter 12 coaxially therein, and the capture catheter 12,which in turn has a lumen configured to house the guidewire tube 6 andthe body of the ALTC device 8. The systems described herein can includethe pusher 202 or corewire 242. Alternatively or in combination, inother methods of use, an end of the ALTC device 201 is coupled to theinner pusher 202. In the second configuration, the inner pusher 202 isadvanced distally to release a portion of ALTC device 201 from a sheath.As the inner pusher 202 is advanced distally, a portion of the collapsedportion 208 becomes the expanded portion of the ALTC device 201. As theinner pusher 202 is advanced distally, the ALTC device 201 is axiallylengthened. In additional or alternative methods of use, the corewire242 can be actuated to axially lengthen the ALTC device 201. Thecorewire 242 can be positioned within the dual lumen shaft 243.Actuation of the corewire 242 such as axially in the appropriatedirection will release the constrained portion of the ALTC device 201.The movement of the corewire 242 can result in axial lengthening orshortening of the ALTC device 201. In some embodiments, the systemsdescribed herein can include a fixed guidewire. In some embodiments, thesystems described herein can be advanced along a guidewire. In someembodiments, the systems described herein can slide along a guidewire.In some embodiments, the systems described herein can include a lumenconfigured to slide along a guidewire. In some embodiments, theguidewire is a shaft. In some embodiments, the guidewire has a lumen. Insome embodiments, the guidewire is a needle. In some embodiments, theguidewire is solid. In some embodiments, the guidewire is flexible. Insome embodiments, the guidewire functions to guide the system within thebody of the patient. In some embodiments, the guidewire functions todeploy one or more components of the device.

The system can include a dual axial lengthening basket and anchorcapture device as described here. The anchors can be any configurationsuch as stent-like, balloon, coils, loops, wire forms into variousgeometric shapes (not shown), etc. such as the embodiments describedherein. In some methods of use, the anchors can function to secure theemboli, thrombus or debris and allow for removal. In some methods ofuse, the anchors can function to break up the emboli, thrombus ordebris. In some embodiments, the ALTC device 201 and the one or moreanchors move or translate together. In some embodiments, the ALTC device201 and the one or more anchors move or translate independently orseparately. In some embodiments, one or more anchors can move as a unitwith another anchor. In some embodiments, one or more anchors can moveindependently or separately from another anchor.

FIG. 73 illustrates an embodiment of an anchor 401. The anchor 401 caninclude any of the features of anchors described herein. In someembodiments, the anchor 401 can comprise symmetric loop shapes. In someembodiments, the anchor 401 can comprise asymmetric loop shapes. In someembodiments, the anchor 401 can comprise polygonal shapes or generallypolygonal shapes. In some embodiments, the anchor 401 comprisesgenerally hexagonal shapes. In some embodiments, the anchor 401 has aconstant diameter. In some embodiments, the anchor 401 has two or morediameters. In the illustrated embodiments, the anchor 401 has analternating larger diameter and smaller diameter. In some embodiments,the smaller diameter is more than 50% of the larger diameter, thesmaller diameter is more than 60% of the larger diameter, the smallerdiameter is more than 70% of the larger diameter, the smaller diameteris more than 80% of the larger diameter, the smaller diameter is morethan 90% of the larger diameter, the smaller diameter is approximatelyequal to the larger diameter, etc. It is also understood the anchor canhave various length. For example, the anchor can have sufficient lengthsuch that the anchor is partially deploy to accommodate the length ofthe clot. Furthermore, the remainder of the anchor is compressed withthe delivery catheter and can be lengthen and expand to accommodatelonger length clot as needed.

In some embodiments, the anchor 401 can be a mesh, braid or othernetwork of wire or thread. In some embodiments, the anchor 401 can havean interlaced structure. In some embodiments, the anchor 401 can beformed from parallel or axial wires or threads 402. The parallel oraxial wires or threads can be coupled or otherwise connected atjunctions 403. The junctions 403 can couple two or more wires or threads402 together. In some embodiments, the junctions 403can be staggered toform the mesh structure. In some embodiments, the anchor 401 forms ahelix. In some embodiments, the anchor 401 forms a double helix. In someembodiments, the anchor 401 forms a helical structure. In someembodiments, the anchor 401 forms an irregular mesh. In someembodiments, the anchor 401 forms a regular mesh. In some embodiments,the anchor 401 forms a fully connected structure. The anchor 401 cancomprise a repeating or tessellating shape such as triangles, squares,or hexagons. The anchor can be laser-cut.

The anchor 401 can include an flexible tip 404. The flexible tip 404 canfunction as atraumatic soft tip. The opposite end of the anchor 401 isattached to the anchor pusher 240 and function in a similar mannerdescribed herein. The flexible tip 404 can be disposed within the outersheath 203 described herein. The anchor pusher 240 can be disposedwithin the dual lumen shaft 243 described herein. The anchor pusher 240can be disposed within any lumen of any device, shaft or catheterdescribed herein. The anchor can be offset to the ALTC device. Theanchor can be coaxial to the ALTC device. The anchor pusher 240 and theanchor 401 can be coupled together such that movement of the anchorpusher 240 causes movement of the anchor 401. In some embodiments, theflexible tip 404, anchor 401 and the anchor pusher 240 is cannulated foran “over the wire” configuration. The anchor pusher 240 can be guidedover a guidewire for placement of the anchor 401.

FIG. 74 illustrates an embodiment of an anchor 405. The anchor 405 caninclude any of the features of anchors described herein, includinganchor 401. In some embodiments, the anchor 405 can be a mesh, braid,laser cut or other network of wire or thread 406. In some embodiment,the anchor is made from one wire or thread. In some embodiments, theanchor 405 can be formed from parallel or axial wires or threads 406.The parallel or axial wires or threads can be coupled or otherwiseconnected at junctions 407. The junctions 407 can couple two or morewires or threads 406 together. In some embodiments, the junctions 407can be staggered to form the mesh structure. In some embodiments, thejunctions 407 can couple all of the wires or threads 406 together. Insome embodiments, the junctions 407 can form a plurality of discretesubsections. In the illustrated embodiments, the anchor 405 can includethree subsections formed from two junctions 407. Other configurationsare contemplated (e.g., the anchor 405 includes two subsections formedfrom one junction 407, the anchor 405 can include four subsectionsformed from three junctions 407, the anchor 405 include five subsectionsformed from four junctions 407, etc.). In the illustrated embodiments,the anchor 405 has an alternating larger diameter and smaller diameterformed by the junctions 407. In some embodiments, the smaller diameteris less than 50% of the larger diameter, the smaller diameter is lessthan 40% of the larger diameter, the smaller diameter is less than 30%of the larger diameter, the smaller diameter is less than 20% of thelarger diameter, the smaller diameter is less than 10% of the largerdiameter, etc. It is also understood the anchor is not limited to metalonly but other materials such as polymeric materials PTFE, PET, Nylon,Polyethylene, PEEK, Polypropylene, Polyimide.

FIG. 75 illustrates a distal end of a capture device system includingthe anchor 401. The system can be placed within a vessel 408. The vesselcan be any target vessel within the body of a patient. In someembodiments, the vessel is in the central nervous system or a coronaryor peripheral vessel as described elsewhere herein. The system is placednear an obstruction 409 or other source of debris or material. In someembodiments, the obstruction is a blood clot. In some embodiments, theobstruction is a neurological blood clot. In some embodiments, theobstruction is an emboli. In some embodiments, the obstruction is aforeign body.

FIG. 75 illustrates the system with the anchor 401 and the ALTC device201 deployed. In some methods of use, one or more steps of releasing ananchor 401 and axially lengthening can occur in any order. In somemethods of use, the anchor 401 is deployed before axial lengthening ofthe ALTC device 201. In some embodiments, the anchor forms only a singleloop. In some embodiments, the single loop functions in a similar mannerto the anchor 401. In some methods of use, the anchor 401 is deployed byaxial movement of the anchor pusher 240. The anchor pusher 240 canrelease the anchor 401 from a sheath such as dual lumen sheath 243described herein. In some methods of use, the anchor 401 is deployed andthen the ALTC device 201 is axially lengthened to cover the anchor 401.In some methods of use, the anchor 401 is deployed before the ALTCdevice 201 is axially lengthened to cover the anchor 401. In somemethods of use, the anchor 401 is partially deployed before the ALTCdevice 201 is axially lengthened to cover the anchor 401. In somemethods of use, the anchor 401 is not deployed before the ALTC device201 is axially lengthened. In some methods of use, the anchor 401 isdeployed after the ALTC device 201 is axially lengthened. In somemethods of use, the anchor 401 is partially deployed after the ALTCdevice 201 is partially axially lengthened. In some methods of use, theanchor 401 is deployed and the ALTC device 201 is axially lengthenedsimultaneously. In some methods of use, the anchor 401 is deployed andthe ALTC device 201 is axially lengthened independently. In some methodsof use, the anchor 401 is fixed and the ALTC device 201 is axiallylengthened. In some methods of use, the ALTC device 201 is fixed and theanchor 401 is deployed or expanded. In some methods of use, the anchor401 is only deployed if covered by the ALTC device 201. In some methodsof use, the anchor 401 is only deployed the ALTC device 201 providesdistal protection. The anchors described herein can function in anymanner described herein.

In some methods of use, the ALTC device 201 is positioned distally tothe anchor 401. In some methods of use, the ALTC device 201 ispositioned downstream in the direction of blood flow. The direction ofblood flow is shown in FIG. 75 by the red arrow. In some methods of use,the ALTC device 201 is positioned distal to the obstruction or clot. Insome methods of use, the ALTC device 201 is positioned to capturefragments of the obstruction. In some methods of use, the ALTC device201 provides distal protection during clot removal. In some methods ofuse, alternatively, the ALTC device 201 is positioned proximally to theanchor 401. In some methods of use, the ALTC device 201 is positionedupstream to the anchor 401. In some methods of use, alternatively, twoor more ALTC device 201 are utilized. In some methods of use, one ALTCdevice 201 is positioned distally and one ALTC device 201 is positionedproximally. In some methods of use, the two ALTC device 201 can movetoward each other. In some methods of use, the two ALTC device 201 canmeet at an intermediate location. The systems described herein caninclude one or more ALTC devices 201. The systems described herein caninclude one or more ALTC devices 201 positioned as described herein. Insome embodiment, the anchor 401 can position distal to the ALTC device201 (not shown).

In some methods of use, the anchor 401 is positioned distally to theALTC device 201. In some methods of use, the anchor can function toblock emboli. In some methods of use, the anchor 401 is positioneddownstream in the direction of blood flow, or upstream in otherembodiments. The direction of blood flow is shown in FIG. 75 by thearrow. In some methods of use, the anchor 401 is positioned distal tothe obstruction or clot. In some methods of use, the anchor 401 ispositioned to capture fragments of the obstruction. In some methods ofuse, the ALTC device 201 is lengthened for clot removal. In some methodsof use, alternatively, two or more the anchors 401 are utilized. In somemethods of use, one, two, or more anchors 401 are positioned distallyand one, two, or more anchors 401 are positioned proximally of the ALTCdevice 201. In some methods of use, the two anchors 401 can move towardeach other. In some methods of use, the two anchors 401 can meet at anintermediate location. The systems described herein can include one,two, or more anchors 401. The systems described herein can include one,two, or more anchors 401 positioned as described herein.

In some embodiments, the anchor is deployed adjacent to the clot. Insome embodiments, the anchor is deployed within the clot. In someembodiments, the anchor is deployed distal to the clot. In someembodiments, the anchor is deployed proximal to the clot. In somemethods of use, the anchor 401 deploys within the obstruction or clot.In some methods of use, the anchor 401 is positioned to entangle theobstruction. In some methods of use, the anchor 401 is positioneddistally to the obstruction or downstream in the direction of bloodflow. In some methods of use, the anchor 401 can move proximally throughthe obstruction. In some methods of use, the anchor 401 is positionedproximally to the obstruction or upstream in the direction of bloodflow. In some methods of use, the anchor 401 can move distally throughthe obstruction. In the illustrated embodiment, the obstruction or clotcan pass through the anchor 401. In the illustrated embodiment, theobstruction or clot can be caught in the anchor 401. In some methods ofuse, the anchor 401 moves after deployment. For instance, the anchor 401can move distally therefore moving the obstruction distally. The anchor401 can move proximally therefore moving the obstruction proximally. Insome embodiments, the anchor 401 can rotate. After deployment of theanchor 401, the obstruction and the anchor 401 can move together as aunit. After deployment of the anchor 401, the obstruction, the anchor401, and the ALTC device 201 can move together as a unit. In somemethods of use, the anchor 401 moves after axially lengthening of theALTC device 201. In some methods of use, the anchor 401 moves beforeaxially lengthening of the ALTC device 201.

FIGS. 76A-76C illustrates the axial lengthening sequence of the ALTCdevice 201, according to some embodiments. The ALTC device 201 can belengthened in any manner described herein. In some methods of use, theALTC device 201 can be lengthened by retraction of a constraining membersuch as a sheath. As the sheath is retracted, the capture guide 204 isexpanded. After the capture guide 204 is expanded, a portion of the ALTCdevice 201 is expanded. In some methods of use, the sheath dual lumensheath 243 can be retracted to axially lengthen the ALTC device 201. Insome embodiments, for the dual lumen sheath 243 in some cases, there maybe no outer sheath required to constrain the device. In someembodiments, the dual lumen sheath 243 constrains the ALTC device 201.In some embodiments, the dual lumen sheath 243 constrains the anchors.In some embodiments, the dual lumen sheath 243 is loaded with the ALTCdevice 201. In some embodiments, the dual lumen sheath 243 is loadedwith the one or more anchor. In some embodiments, the ALTC device 201and the one or more anchor are loaded in a single lumen of a singlelumen sheath. In some embodiments, the ALTC device 201 and the one ormore anchor are loaded in a single lumen of a dual lumen sheath. In someembodiments, the ALTC device 201 and the one or more anchor are loadedin separate lumens of a sheath. In some embodiments, the ALTC device 201and the one or more anchor are advanced from a single lumen of a singlelumen sheath. In some embodiments, the ALTC device 201 and the one ormore anchors are advanced from a single lumen of a dual lumen sheath. Insome embodiments, the ALTC device 201 and the one or more anchors areadvanced from separate lumens of a sheath. In some embodiments, thedevice would be loaded in a sheath/guide/microcatheter in advance.Effectively, in some cases the guide/microcatheter can be used as asheath.

In some embodiments, the ALTC device 201 maintains the diameter of thecapture guide 204. In some methods of use, the ALTC device 201 can belengthened by extension of a member such as a pusher 202 or corewire242. Alternatively or in combination, in other methods of use, the innerpusher 202 is advanced distally to advance an end of the ALTC device201. As described herein, an end of the ALTC device 201 is coupled tothe inner pusher 202. In the second configuration, the inner pusher 202is advanced distally to release a portion of ALTC device 201 from asheath. As the inner pusher 202 is advanced distally, a portion of thecollapsed portion 208 becomes the expanded portion of the ALTC device201. As the inner pusher 202 is advanced distally, the ALTC device 201is axially lengthened.

FIG. 76A illustrates the system after deployment of the anchor 401. Insome methods of use, the anchor 401 is deployed before axial lengtheningof the ALTC device 201. The capture guide 204 is expanded and a portionof the ALTC device 201 is expanded. FIG. 76A illustrates the axiallengthen device or ALTC device 201 with an expandable anchor 401positioned near the opening end of the ALTC device 201. In someembodiments, the expandable anchor 401 can be independently movable suchthat expandable anchor 401 can retract proximally or distally while theALTC device 201 is stationary. In some embodiments, alternatively, theanchor 401 and the ALTC device 201 can move together as one unit. Insome embodiments, the ALTC device 201 and the expandable anchor 401 arecollapsed in the delivery configuration. In some embodiments, the ALTCdevice 201 and the expandable anchor 401 are expanded when deployedwithin the target vessel.

FIG. 76B illustrates the axial lengthening of the expanded portion ofthe ALTC device 201. In some methods of use, the ALTC device 201 islengthening proximally to encapsulate the anchor 401. In some methods ofuse, the anchor 401 has captured an obstruction or clot. In some methodsof use, the ALTC device 201 is lengthening proximally to encapsulate theobstruction or clot. In some methods of use, the ALTC device 201 islengthening proximally to encapsulate only a portion of the anchor 401.The collapsed portion 208 of the ALTC device 201 is shortened as theALTC device 201 is axially lengthened. In some methods of use, the ALTCdevice 201 is not lengthened proximally to encapsulate a portion of theanchor 401. In some methods of use, the ALTC device 201 and the anchor401 remain in the position shown in FIG. 76A during clot removal.

FIG. 76C illustrates the axial lengthening of the expanded portion ofthe ALTC device 201. The ALTC device 201 is lengthening proximally tocapture the clot secured by the anchor 401. In some methods of use, theALTC device 201 is lengthening proximally to circumscribe the entireanchor 401. The collapsed portion 208 of the ALTC device 201 isshortened as the ALTC device 201 is lengthened. For instance, collapsedportion 208 has a smaller axial length in FIG. 76C than in FIG. 76B.FIG. 76C illustrates the axial lengthening ALTC device 201 is sufficientto completely capture the clot. In some methods of use, the ALTC device201 and the anchor 401 can retract proximally to remove the clot. Insome methods of use, the ALTC device 201 and the anchor 401 can retractproximally while the configuration shown in FIG. 76A. In some methods ofuse, the ALTC device 201 and the anchors 401 can retract proximallywhile the ALTC device 201 does not circumscribe the entire anchor 401.

In FIG. 76C, the deployed and expanded ALTC device 201 is longer, e.g.,in length, than the deployed and expanded ALTC device 201 in FIG. 76B.The collapsed portion 208 resides inside the outer sheath 203 or duallumen shaft 243 and is shorter in FIG. 76C than in FIG. 76B. Thediameter or cross-section of the ALTC device 201 can remain constant orsubstantially constant during axially lengthening. The diameter orcross-section of the ALTC device 201 can in some cases remain constantbetween the initial deployed configuration shown in FIG. 76A and theexpanded configurations shown in 76B and 76C. In some embodiments, twoor more steps can occur simultaneously. In some methods of use, theanchor 401 is partially deployed and the ALTC device 201 is axiallylengthened to cover the anchor 401 simultaneously.

FIGS. 77A-77C illustrate additional views of the system. The anchor 405,or any of the anchors described herein, can be deployed in a similarmanner as anchor 401. In some embodiments, the ALTC device 201 isaxially lengthened with the expandable anchor 401 positioned near theopening end of the ALTC device 201. In some embodiments, the ALTC device201 is extended over the expandable anchor 401. In some embodiments, theALTC device 201 is positioned distal to the obstruction, clot, emboli,and/or foreign body for distal protection. In some embodiments, the ALTCdevice 201 is positioned distally or downstream in the direction ofblood flow. In some embodiments, the expandable anchor 401 is deployedwithin the obstruction. In some embodiments, the ALTC device 201retracts proximally over the expandable anchor 401 and the obstruction.In some embodiments, the obstruction is removed. In some embodiments,the ALTC device 201 is positioned distal to the obstruction for distalprotection. In some embodiments, the expandable anchor 401 deployswithin the obstruction and retracts to remove the obstruction while theALTC device 201 remains in position. In some embodiments, the ALTCdevice 201 retracts subsequently to remove emboli. In some embodiments,the expandable anchor 401 and the ALTC device 201 retract as one unit toremove the obstruction. In some embodiments, the ALTC device 201 isretracted over the expandable anchor and obstruction and the entiredevice is removed.

FIG. 78 illustrates another embodiment of an anchor 410. The anchor 410can include any of the features of anchors described herein. In someembodiments, the anchor 410 can include a balloon. Balloon materials canbe compliant, semi-compliant, or non-compliant. In some embodiments, theanchor 410 can comprise a spherical balloon. In some embodiments, theanchor 410 can comprise an oblong balloon. In some embodiments, theanchor 410 can include one or more shaped ends, including conical,square, spherical, tapered, etc. In some embodiments, the anchor 410 canincludes a dog bone shaped with proximal and distal areas of increaseddiameter balloon or stepped balloon having two or more differentdiameters. In some embodiments, the anchor 410 can include an axially orradially offset balloon. In some embodiments, the anchor 410 cancomprise any shape including a conical balloon, tapered balloon, steppedballoon, square balloon, polygonal balloon, etc. In some embodiment, theballoons can be in series or in parallel or circumferentially orradially. Additional balloon shapes are disclosed in U.S. patentapplication Ser. No. 11/851,848, filed Sep. 7, 2007 and published Jul.23, 2013 as U.S. Pat. No. 8,491,623 (“Vogel”), which is incorporated byreference in its entirety. In some embodiments, the anchor 410 has adiameter. In some embodiments, the anchor 410 has two or more diameters.In some embodiments, the smaller diameter is more than 50% of the largerdiameter, the smaller diameter is more than 60% of the larger diameter,the smaller diameter is more than 70% of the larger diameter, thesmaller diameter is more than 80% of the larger diameter, the smallerdiameter is more than 90% of the larger diameter, the smaller diameteris approximately equal to the larger diameter, etc. In some embodiments,two or more anchors 410 have the same shape. For instance, two or moreanchors 410 can be spherical. In some embodiments, two or more anchors410 can be identical. In some embodiments, two or more anchors 410 havea different shape. For instance, the first anchor 410 can be sphericaland the second anchor 410 can be oblong. In some embodiments, two ormore anchors 410 have a different diameter or cross-section. FIG. 78illustrates the ALTC device 201 with a single balloon. In someembodiments, the balloon is independently movable relative to the ALTCdevice 201. In some embodiments, the balloon and ALTC device 201 canalso retracted as one unit. FIG. 79 for example illustrates balloons 410are positioned in series. In some embodiment, the balloons can positionside-by-side, in parallel, circumferentially, and/or radially. Furtherin some embodiments, the balloons' shape and diameter can be configuredso that there are gaps between the balloons to allow potential bloodflow.

In some embodiments, the anchor 410 can be inflated. In someembodiments, an inflation medium such as gas or liquid is supplied tothe anchor 410. In some embodiments, the anchor 410 can be inflated toform a rigid body. In some embodiments, the anchor 410 can be inflatedto transmit a force to the obstruction, such as force to compress ormove the obstruction. In some embodiments, the anchor 410 can bedeflated. The inflation medium can be removed from the anchor 410. Insome embodiments, the anchor 410 has a rough or textured outer surface.In some methods of use, the anchor 410 becomes entangled with theobstruction or clot described herein. In some embodiments, the anchor410 has a smooth outer surface. In some embodiments, the anchor 410 cancompress the obstruction or clot thereby opening the blood vessel. Theanchor 410 can apply a compressive force on the obstruction duringinflation of the anchor 410. In some embodiments, the anchor 410 can beself-deployed. In some embodiments, the anchor 410 can include a shapememory material to deploy the anchor 410.

FIG. 79 illustrates an embodiment including a plurality of anchors, suchas a first anchor 410, a second anchor 410, a third anchor 410, and afourth anchor 410. The system can include one or more of the anchors410. In the illustrated embodiment, the system includes four anchors 410but other configurations are contemplated (e.g., two anchors, threeanchors, five anchors, six anchors, seven anchors, eight anchors, nineanchors, ten anchors, etc.). In some embodiments, two or more anchors410 are inflated simultaneously. For instance, the anchors 410 can becoupled such that fluid can flow between the anchors 410. In someembodiments, two or more anchors 410 are inflated independently. Forinstance, each anchor can be separately supplied fluid for inflation, orinclude a common inflation lumen. In some embodiments, two or moreanchors 410 are inflated in series. In some embodiments, two or moreanchors 410 are inflated in parallel. In some embodiments, two or moreanchors 410 are deflated simultaneously. In some embodiments, two ormore anchors 410 are deflated independently. In some embodiments, two ormore anchors 410 are deflated in series. In some embodiments, two ormore anchors 410 are deflated in parallel. The two or more anchors 410can be coupled via an inflation lumen 411. The inflation lumen 411 canallow delivery of the fluid to inflate the anchors.

FIG. 79 illustrates the ALTC device 201 with a series of balloonspositioned near the opening end of the ALTC device 201. In someembodiments, the balloons are independently movable relative to the ALTCdevice 201. In some embodiments, the balloons and the ALTC device 201can also retracted as one unit. In some embodiments, the balloonsfunction as anchors as described herein to entangle the clot. In someembodiments, the balloons function to compress the clot to open thetarget vessel. Other functions for the balloons are contemplated. Insome embodiments, the balloons have a uniform size and shape, but can bepositioned adjacent each other in order of increasing or decreasingdiameter, or have different shapes in some embodiments.

FIG. 80 illustrates the system within the vessel 408 with theobstruction 408 after deployment of the anchors 410. In some methods ofuse, the anchors 410 are inflated before axial lengthening of the ALTCdevice 201. In some methods of use, one or more steps of deploying orinflating anchors 410 and axially lengthening can occur in any order. Insome methods of use, the anchors 410 are inflated and then the ALTCdevice 201 is axially lengthened to cover the anchors 410. In somemethods of use, two or more anchors 410 can be inflated before the ALTCdevice 201 is axially lengthened. In some methods of use, the anchors410 are fixed such that the anchors 410 need not be inflated. In somemethods of use, one or more anchors 410 are deflated before the ALTCdevice 201 is axially lengthened. In some methods of use, one or moreanchors 410 are inflated after the ALTC device 201 is axiallylengthened. In some methods of use, the anchors 410 are inflated and theALTC device 201 is axially lengthened simultaneously. In some methods ofuse, the anchors 410 are inflated and the ALTC device 201 is axiallylengthened independently. In some methods of use, the anchors 410 areonly inflated if covered by the ALTC device 201.

FIG. 80 illustrates the ALTC device 201 positioned distal to theobstruction. FIG. 80 illustrates the balloons expanding within theobstruction. In some embodiments, one or more anchors 410 are positioneddistally to the obstruction before inflation. After inflation, the oneor more distal anchors 410 can push the obstruction proximally. In someembodiments, one or more anchors 410 are positioned proximally to theobstruction before inflation. After inflation, the one or more distalanchors 410 can push the obstruction distally toward the ALTC device201.

In some methods of use, the ALTC device 201 is positioned distally tothe anchors 410. In some methods of use, the ALTC device 201 providesdistal protection during clot removal, akin to a filter in some cases.In some methods of use, the anchors 410 inflate within the obstruction.In some methods of use, the anchors 410 are positioned to entangle theobstruction. In some methods of use, the anchors 410 move afterdeployment. In some methods of use, the anchors 410 move simultaneously.In some methods of use, the anchors 410 move independently, or all inconcert in some cases. In some methods of use, the anchors 410 movedistally therefore moving the obstruction distally. In some methods ofuse, the anchors 410 move toward the ALTC device 201. After deploymentof the anchors 410, the obstruction and the anchors 410 can movetogether as a unit. In some methods of use, the anchors 410 move afteraxially lengthening of the ALTC device 201. In some methods of use, theanchors 410 move before axially lengthening of the ALTC device 201.

FIG. 81 illustrates an embodiment of an anchor 415. The anchor 415 caninclude any of the features of anchors described herein. In someembodiments, the anchor 415 can comprise a disk. In some embodiments,the anchor 415 can be arcuate shaped such as round or circular, orovoid. In some embodiments, the anchor 415 can have a constant orvariable diameter. In some embodiments, the anchor 415 can be any shape,including a polygon, elliptical, etc. In some embodiments, the anchor415 can be entirely flat or have flat surfaces. In some embodiments, theanchor 415 can be concave, convex, or another curved shaped. Forinstance, a first surface 416 of the anchor 415 can be concave and asecond surface 417, opposite the first surface can be concave. Forinstance, a first surface 416 of the anchor 415 can be convex and asecond surface 417, opposite the first surface can be convex. In someembodiments, the anchor 415 can have a smooth outer surface. In someembodiments, the anchor 415 can include a roughened or porous outersurface. The anchor can conform when contacting a surface such as avessel wall.

In some embodiments, the anchor 415 can be deployed similar to anchor241. In some embodiments, the anchor 415 can self-deploy. In someembodiments, the anchor 415 can include a shape memory material todeploy the anchor 415. In some embodiments, the anchor 415 can beinflated. In some embodiments, an inflation medium such as gas or liquidis supplied to the anchor 415. In some embodiments, the anchor 415 canbe deflated. FIG. 81 illustrates the ALTC device 201 with a single diskpositioned proximal to the ALTC device 201. In some embodiments, theexpandable disk is independently movable relative to the ALTC device201. In some embodiments, the expandable disk and ALTC device 201 canalso be retracted as one unit. In some embodiment, the anchor 415 isadjacent, side-by-side or offset to the ALTC device 201. In someembodiment, the anchor 415 is coaxial or in-line to the ALTC device.

FIG. 82 illustrates an embodiment including a first anchor 415, a secondanchor 415, a third anchor 415, a fourth anchor 415, a fifth anchor 415,and a sixth anchor 415. The system can include one, two, or more of theanchors 415. In the illustrated embodiment, the system includes sixanchors 415 but other configurations are contemplated (e.g., about, atleast about, or no more than about two anchors, three anchors, fouranchors, five anchors, seven anchors, eight anchors, nine anchors, tenanchors, etc.). In some embodiments, the anchor 415 comprises a helix orhelical structure. For instance, the first anchor 415 can be joined withthe second anchor 415 to form a helix. A helical anchor is disclosed,for example, in FIG. 6A of PCT/IB2014/066389, filed Nov. 27, 2014 andpublished Jun. 4, 2015 as WO 2015/079401 (“Yachia”), which isincorporated by reference in its entirety.

In some embodiments, two or more anchors 415 are deployedsimultaneously. In some embodiments, two or more anchors 415 aredeployed independently. For instance, the first anchor 415 and thesecond anchor 415 can be deployed independently. In some embodiments,two or more anchors 415 are deployed in series. For instance, the firstanchor 415 can be deployed before the second anchor 415. In someembodiments, two or more anchors 415 are deployed in parallel. FIG. 82illustrates the ALTC device 201 with a series of expandable diskspositioned proximal to the ALTC device 201. In some embodiments, theexpandable disks are independently movable relative to the ALTC device201. In some embodiments, the expandable disks and ALTC device 201 canalso be retracted as one unit.

FIG. 83 illustrates the system within the vessel 408 with theobstruction 409. In some methods of use, one or more steps of deployingor inflating anchors 415 and axially lengthening can occur in any order.In some methods of use, the anchors 415 are deployed before axiallengthening of the ALTC device 201. In some methods of use, one or moreanchors 415 are deployed before the ALTC device 201 is axiallylengthened to cover the anchors 410. In some methods of use, one or moreanchors 415 are deployed after the ALTC device 201 is axiallylengthened. In some methods of use, the anchors 415 are deployed and theALTC device 201 is axially lengthened simultaneously. In some methods ofuse, the anchors 415 are only deployed if covered by the ALTC device201. FIG. 83 illustrates the ALTC device 201 positioned distal to theobstruction and the expandable disks deployed within the obstruction.The single disk embodiment shown in FIG. 81 can be deployed within theobstruction in a similar manner. In some methods of use, the ALTC device201 is positioned distally to the anchors 415. In some methods of use,the ALTC device 201 provides distal protection during clot removal. Insome methods of use, the anchors 415 deploy within the obstruction orclot. In some methods of use, the anchors 415 move after deployment.

FIG. 84 illustrates an embodiment of an anchor 420. The anchor 420 caninclude any of the features of anchors described herein. In someembodiments, the anchor 420 can comprise a funnel. In some embodiments,the anchor 420 can include a round or circular opening. In someembodiments, the anchor 420 can taper from a larger diameter orcross-section to a smaller diameter or cross-section. In someembodiments, the anchor 420 can taper along the length of the anchor420. In some embodiments, the anchor 420 can be any generally conicalshape. In some embodiments, the anchor 420 can include an inflectionpoint. In some embodiments, the anchor 420 can include a radiallyoutward flare. In some embodiments, the anchor 420, or a surfacethereof, is concave. In some embodiments, the anchor 420, or a surfacethereof, is convex. In some embodiments, the anchor 420 can have asmooth outer surface. In some embodiments, the anchor 420 can include aroughened or porous outer surface. In some embodiment, the anchor 420 isadjacent, side-by-side or offset to the ALTC device 201. In someembodiment, the anchor 420 is coaxial or in-line to the ALTC device.

In some embodiments, the anchor 420 is formed as a mesh or braid, lasercut or stent structure. The funnel shape of the anchor 420 can in somecases assist in retrieving and containing the obstruction or clot. Insome embodiments, the anchor 420 comprises structural features to assistin the deployment of the funnel shape, such as to hold the rim 421 ofthe funnel shape open. In some embodiments, the anchor 420 can includestruts comprising a shape memory or self-expanding material such asnitinol, or other stent structure, mesh, and/or webbing. In someembodiments, the anchor 420 can be deployed similar to anchor 241. Insome embodiments, the anchor 420 can be self-deployed. In someembodiments, the anchor 420 can include a shape memory material todeploy the anchor 420. The anchor 420 can include a rim 421. The rim 421can include any of the features of the capture guides described herein.

In some embodiments, the proximal end opening of the anchor 420 includesthe rim 421 that takes the form of, in some embodiments, a radiallyexpandable shape memory partial or full ring-like annular structure. Therim 421 expands once freed or released from a constraining member suchas any sheath or tube described herein. In some embodiments, the rim 421is coupled with a portion of a mesh, interlaced structure, or covering422. In some other embodiments, the rim 421 and the proximal end of thecovering 422 can be sutured in place using silk or polymeric filamentssuch as Ultra-High Molecular Weight polyethylene, Nylon, PET, PTFE. Insome embodiments, the covering 422 comprises with a low durometerpolymeric material.

The rim 421 and/or the covering 422 can be formed, for example, frommetallic, shape memory, or other appropriate materials. In someembodiment, the rim 421 can include a loop configuration and be formedfrom nitinol shape memory wire of various geometries such as round,oval, elliptical, flat, and the like. The rim 421 can be formed ofdifferent shapes such as a circular loop, oval loop, z-shape, etc. Insome embodiment, the rim 421 can be shaped set either into coils,multiple full circles, full circle or partial circles where the ends ofthe wire formed into two legs. The partial circle can be from, forexample, 180 degrees to 359 degrees or 220 degrees to 359 degrees. Thelegs can be configured to be off-axis to the loop such that it can beright angle, acute or obtuse angle relative to the loop. It can bearcuate and form a partial or full ring as illustrated, and cancircumscribe or otherwise form an outer diameter, and define theproximal-most end of the anchor 420. The anchor 420 can in someembodiments include a single loop or multiple loops positioned along thelength of the covering 422. The anchor 420 can be configured to becompressed and positioned within a lumen of a shaft during introductioninto the vascular system where the anchor 420 is configured to bepositioned coaxially within the obstruction or clot. In some methods ofuse, the anchor 420 is configured to be deployed to entangle with theobstruction or clot.

FIG. 84 illustrates the ALTC device 201 with an expandable funnel likeanchor. In some embodiments, the funnel shaped anchor is positionedproximal to the ALTC device 201. In some embodiments, the funnel shapedanchor is independently movable relative to the ALTC device 201. In someembodiments, alternatively, the anchor and ALTC device 201 can move asone unit.

FIG. 85 illustrates an embodiment including a plurality of anchors, suchas a first anchor 420, a second anchor 420, a third anchor 420, a fourthanchor 420, and a fifth anchor 420. The system can include one or moreof the anchors 420. In the illustrated embodiment, the system includesfive anchors 420 but other configurations are contemplated (e.g., twoanchors, three anchors, four anchors, six anchors, seven anchors, eightanchors, nine anchors, ten anchors, etc.). In some embodiments, two ormore anchors 420 are deployed simultaneously. In some embodiments, twoor more anchors 420 are deployed independently. For instance, the firstanchor 420 and the second anchor 420 can be deployed independently. Insome embodiments, two or more anchors 420 are deployed in series. Forinstance, the first anchor 420 can be deployed before the second anchor420. In some embodiments, two or more anchors 420 are deployed inparallel. FIG. 85 illustrates the ALTC device 201 with expandable funnellike anchors. In some embodiments, the funnel shaped anchors arepositioned proximal to the ALTC device 201. In some embodiments, thefunnel shaped anchors are independently movable relative to the ALTCdevice 201. In some embodiments, alternatively, the anchors and ALTCdevice 201 can move as one unit.

FIG. 86 illustrates the system within the blood vessel 408 and theobstruction 409. In some methods of use, one or more steps of deployingone or more anchors 420 and axially lengthening can occur in any order.In some methods of use, one or more anchors 420 are deployed beforeaxial lengthening of the ALTC device 201. In some methods of use, theanchors 420 are deployed before the ALTC device 201 is axiallylengthened to cover the anchors 420. In some methods of use, one or moreanchors 420 are deployed after the ALTC device 201 is axiallylengthened. In some methods of use, the anchors 420 are deployed and theALTC device 201 is axially lengthened simultaneously. In some methods ofuse, the anchors 420 are deployed and the ALTC device 201 is axiallylengthened independently. In some methods of use, the anchors 420 areonly deployed if covered by the ALTC device 201. In some methods of use,the ALTC device 201 is positioned distally to the anchors 420. In somemethods of use, the ALTC device 201 provides distal protection duringclot removal. In some methods of use, the anchors 420 deploy within theobstruction or clot. In some methods of use, the anchors 420 move afterdeployment.

FIG. 86 illustrates an embodiment in which the anchors 420 face forward.The anchors 420 can taper inward from a distal end 423 to a proximal end424. The rim 421 of each anchor 420 can be located at the distal end 423of each anchor 420. FIG. 87 illustrates a system with anchors 420deployed within a vessel 408 comprising an obstruction 409. FIG. 87illustrates an embodiment in which the anchors 420 face backward. Theanchors 420 can taper inward from the proximal end 424 to a distal end423. The rim 421 of each anchor 420 can be located at the proximal end424 of each anchor 420. In some embodiments, the anchors 420 have asingle configuration, e.g., all anchors 420 face forward as shown inFIG. 86, all anchors 420 face backward as shown in FIG. 87. In someembodiments, two or more anchors 420 have a different configuration,e.g., the first anchor 420 faces forward and the second anchor 420 facesbackward. In some embodiments, the anchor 420 can switch between facingforward and facing backward. In some embodiments, the anchors 420 can beconfigured to roll out, invert, evert, and/or variably lengthenproximally or distally between facing forward and facing backward. Insome embodiments, one or more anchors 420 can be configured to switchbetween facing forward and facing backward. In some embodiments, one ormore anchors 420 can be fixed as either facing forward or facingbackward. FIGS. 86 and 87 illustrate the ALTC device 201 positioneddistal to the obstruction. FIGS. 86 and 87 illustrate the expandablefunnel shape anchors deployed within the obstruction.

The anchors described herein can have any shape. Other expandable shapesand/or geometric anchors are contemplated. In some embodiments, theanchor can be shaped as a coil. In some embodiments, the anchor can beshaped as a loop. In some embodiments, the anchor can be shaped as aclover. In some embodiments, one or more anchors are offset to the ALTCdevice 201. In some embodiments, the anchor can be coaxial to the ALTCdevice 201 wherein the anchors can be attached to the shaft of the ALTCdevice 201. In some embodiments, this configuration allows the anchorand the axial lengthen device move as one unit.

U.S. patent application Ser. No. 14/602,014, filed Jan. 21, 2015 andpublished Aug. 9, 2016 as U.S. Pat. No. 9,408,620 (“Rosenbluth”); U.S.patent application Ser. No. 08/723,619, filed Oct. 20, 1996 andpublished Apr. 20, 1999 as U.S. Pat. No. 5,895,398 (“Wensel”); U.S.patent application Ser. No. 08/968146, filed Nov. 12, 1997 and publishedSep. 7, 1999 as U.S. Pat. No. 5,947,985 (“Imran”); U.S. patentapplication Ser. No. 09/756476, filed Jan. 8, 2001 and published Dec.16, 2003 as U.S. Pat. No. 6,663,650 (“Sepetka”); U.S. patent applicationSer. No. 09/789332, filed Feb. 20, 2001 and published Jan. 11, 2005 asU.S. Pat. No. 6,840,950 (“Sanford”); U.S. patent application Ser. No.12/581,960, filed Oct. 20, 2009 and published Jan. 10, 2012 as U.S. Pat.No. 8,092,486 (“Berrada”); U.S. patent application Ser. No. 11/580,546,filed Oct. 13, 2006 and published Aug. 28, 2012 as U.S. Pat. No.8,252,017 (“Paul”); U.S. patent application Ser. No. 12/564892, filedSep. 22, 2009 and published Oct. 30, 2012 as U.S. Pat. No. 8,298,252(“Krolik”) are all incorporated by reference herein in their entireties.

In some embodiments, the clot treatment device described by Rosenbluthet al. can be used in place of, or in combination with, the anchorsdescribed herein. Referring now to FIGS. 88A-88H, embodiments of ananchor 425 are disclosed. Referring to FIG. 88A, the radially extendingportions 426 between the generally cylindrical sections 427 of theanchor 425 are defined by a cylindrical disk shape with a roundedtriangular cross-section. Referring to FIG. 88B, the radially extendingportions 426 between the generally cylindrical sections 427 of theanchor 425 are defined by a cylindrical disk shape with a roundedtriangular cross-section wherein the diameter of the disk increasesalong the length of the anchor 425 thus forming a conical exteriorextent. Referring to FIG. 88C, the radially extending portions 426between the generally cylindrical sections 427 of the anchor 425 aredefined by a cylindrical disk shape with a rectangular cross-section.Referring to FIG. 88D, the radially extending portions 426 between thegenerally cylindrical sections 427 of the anchor 425 are defined by acylindrical disk shape with a linear (non-rounded) triangularcross-section. Referring to FIG. 88E, some of the radially extendingportions 426 between the generally cylindrical sections 427 of theanchor 425 are defined by a cylindrical disk shape with a roundedcross-section and others have a rectangular cross section. Referring toFIG. 88F, the radially extending portions 426 between the generallycylindrical sections 427 of the anchor 425 alternate between cylindricaldisk shape with a T-shaped cross-section and a flare-shapedcross-section. Referring to FIG. 88G, the radially extending portions426 between the generally cylindrical sections 427 of the anchor 425 aredefined by a partial cylindrical disk shapes. Referring to FIG. 88H, theradially extending portions 426 between the generally cylindricalsections 427 of the anchor 425 are defined by tabs and bumps orprotuberances arising from the cylindrical surface of the anchor 425. Insome embodiments, the anchors described herein provide greater surfacearea along the anchor than an anchor that is uniformly cylindrical. Insome methods of use, the increased surface area facilitates thetreatment and/or retrieval of the obstruction or clot.

In some embodiments, the anchor 425 can have a generally cylindricalshape that, during use, provides a flow lumen for blood across a clot.The anchor 425 is not, however, limited to a generally cylindricalshape. For example, the shape can be generally conical, generallyconcave or generally convex along its axis, so long as such shapesprovide the aforesaid lumen for blood flow. In some embodiments, theanchor 425 also has a series of radially extending portions 426 whichare separated by generally cylindrical portions 427. In someembodiments, the clot treatment device 425 can be porous so as to allowthe flow of blood therethrough. In some embodiments, the anchor 425 ismade from a mesh or braided material. The material can be a superelasticmaterial such as nitinol or an alternative material such as cobaltchrome alloy. In some embodiments, the anchor 425 can be made from awire lattice, wire braid or stent. In some embodiments, the anchor 425can be self expanding.

In some embodiments, the anchor radially expands into the clot. In somemethods of use, at least a portion of the anchor expands distal of theclot. As shown in some figures herein, at least one of the anchors of aplurality of anchors can be located distal to the clot upon expansion ofthe anchors. In some methods of use, upon expansion of the anchor, bloodflowthrough the clot is restored. More specifically, the blood is nowfree to move through the mesh of the anchor and exit the anchor distalto the clot. As a result, the acute condition of blockage is correctedthus immediately improving the circulation of oxygenated blood in thepatient. The expansion, inflation, or deployment of the anchorsdescribed herein can impinge or cut into the clot material. Thisentanglement can enhance the subsequent removal of the clot sinceportions of the clot collect between the radially extending portions426; through the pores of the mesh forming the radially extendingportions 426; along the longitudinal cylindrical sections 427 betweenthe radially extending portions 426 of the anchor 425; and/or within theanchor 425 itself.

In some methods of use, the deployment of the anchor 425 results in anoutwardly expanding generally cylindrical force being urged against aninner surface of the clot. In some methods of use, this force pushes theclot material outwardly and creates a lumen through which blood flow isrestored. In some methods of use, the outwardly expanding generallycylindrical force can vary in magnitude along the axis of the anchor,due in part to the shape of the anchor. In some embodiments, thedeployment of the anchor changes the angular orientation of the anchorwith respect to the axis of the system. In some methods of use, thisangular change or twisting can improve or enhances adherence of clotmaterial to the anchor 425.

The clot treatment devices disclosed in Rosenbluth may be included in asystem with the ALTC device 201 described herein. The ALTC device 201can surround the clot treatment devices similar to the anchors describedherein. After the clot treatment device has been expanded, the ALTCdevice 201 can be axially lengthened to capture the clot. In oneembodiment, the clot treatment device and the ALTC device 201 are pulledback simultaneously in a proximal direction. This is followed by theentire system being withdrawn.

The clot and foreign body removal device of Wensel can be used in placeof, or in combination with, the anchors described herein. Referring nowto FIGS. 88I-88J, embodiments of the anchor 428 are disclosed. Theanchor 428 can be a clot capture coil. In some embodiments, the coil ismade from a flexible solid elastic or superelastic material which hasshape memory, e.g., it can deform to a straight position and then returnto a resting coil configuration. In some embodiments, the coil is madeout of a solid nitinol wire with a diameter of, e.g., about 0.0005inches to about 0.038 inches. Nitinol is preferred in some cases becauseof its superelasticity and its shape memory. However, other solidmaterials that are also elastic or superelastic and have shape memorycould also be used such as some synthetic plastics, metallic alloys, andthe like. The diameter of the coils can vary depending on the size ofthe vessel occluded. The diameter can range from about 1 mm for smallvessels to about 30 mm for large vessels such as the pulmonary arteriesor inferior vena cava. The length of the coil can also vary buttypically ranges from about 3 to about 300 mm in the proximal to distaldirection. Because the nitinol coil is superelastic, the coil can beextended to a completely straight configuration with the use of minimalforce and then reform to its natural resting configuration when theforce is removed. In some embodiments, the coil is made out of a solidbiphasic material which changes shape upon heating or the passage ofelectric current. In some embodiments, the coil is cone-shaped.

In some embodiments, the anchors described herein can comprise a shapememory body. The anchor can comprise a single wire or multiple wires.The anchor can comprise one or more loops. The anchor can comprise oneor more helices. In some embodiments, the loops and/or helices can havean increasing diameter from proximal to distal end of the anchor. Insome embodiments, the loops and/or helices can have a decreasingdiameter from proximal to distal end of the anchor. In some embodiments,the loops and/or helices can have a variable diameter from proximal todistal end of the anchor.

The apparatus of Imran can be used in place of, or in combination with,the anchors described herein. Referring now to FIG. 88K, an embodimentof the anchor 429 is disclosed. The anchor 429 can include a brush. Thebrush is formed on the distal extremity of the flexible elongate tubularmember. The brush is comprised of a plurality of radially extendingbristles formed of a suitable soft material such as Nylon with the brushhaving an outer diameter corresponding generally to the inner diameterof the lumen defined by the wall. The distal extremity is provided witha plurality of randomly disposed ports interposed between the bristlesfor supplying irrigation liquid to the brush. With irrigation liquidbeing supplied through the ports and aspiration taking place through theaspiration port, the brush can be rotated by rotating the proximalextremity of the therapeutic catheter. By moving the catheter back andforth, the bristles can come into engagement with the wall throughoutthe entire length of the chamber to remove the plaque in smallparticles. As the small particles are removed they can be aspirated fromthe chamber through the aspiration port.

The obstruction removal device of Sepetka can be used in place of, or incombination with, the anchors described herein. Referring now to FIGS.88L-88M, the obstruction removing device 430 has an engaging element 431extending from an insertion element 432. The engaging element 431 ismovable from a collapsed position to an expanded position. When theengaging element 431 is contained within a sheath or other member, theengaging element 431 is in a relatively straight configuration. Theengaging element 431 has a distal portion, which forms a relativelyclosed structure, which can catch or trap the obstruction, or any partthereof, to prevent migration of the obstruction or part thereof. Theengaging element has a proximal portion which is formed with smallercoils than the distal portion. The proximal portion engages theobstruction as described below. The engaging element 431 preferably hasa number of markers which provide an indication as to how much of theengaging element extends from the sheath. For example, markers mayindicate when the engaging element 431 is ½, ¾ or fully exposed. In thismanner, the user may quickly advance the engaging element 431 throughthe sheath without inadvertently exposing and advancing the engagingelement 431 out of the sheath. The markers can also be used to provide acontrolled diameter of the engaging element 431 since the diameter ofthe engaging element is known for the various positions corresponding tothe markers. The markers may also be used to size the vessel in whichthe engaging element 431 is positioned by observing when the engagingelement 431 engages the vessel walls and determining the size of theengaging element 431 using the markers.

The engaging element 431 is preferably made of a superelastic material,such as nitinol, and has a diameter of, in some cases, about 0.005-0.018inch, about 0.005-0.010 inch or about 0.008 inch. The engaging element431 can have a rounded, atraumatic tip to prevent damage to the vesseland facilitate advancement through the vessel and/or sheath. Aradiopaque wire, such as platinum ribbon having a width of 0.004 inchand a thickness of 0.002 inch, is preferably wrapped around the engagingelement 431 to improve radiopacity. The device is preferablyself-expanding but may also be expanded with an actuator. The actuatoris preferably a thin filament which is tensioned to move the device tothe expanded position. An advantage is that the filament extends throughthe same lumen as the device thereby minimizing the overall size of thedevice. It is understood that throughout discussion of the devices andmethods herein that any of the anchors described herein may be expandedusing the actuator rather than being self-expanding. The obstructionremoval device shown in FIG. 88M has a first section with largerdiameter coils than a second section. A third section also has largercoils than the second section with the second section positioned betweenthe first and third sections. The obstruction removal device may have anumber of alternating small and large sections which can enhance theability of the obstruction removal device to engage variousobstructions. The obstruction removal device can have four largesections with relatively large coils and three sections having smallercoils, but other configurations are contemplated with different numbersof sections.

The expansion elements of Sanford can be used in place of, or incombination with, the anchors described herein. Referring now to FIG.88N, an anchor 433 is shown. The anchor 433 can include a helicalexpansion ring connected to the inlet of the anchor. Expansion ring hasa proximal end and a distal end. The distal end can be fixed toguidewire. Alternately, the anchor could have resilient, expansionmaterial embedded in its inlet. The anchor can include inclined “sail”at its inlet. The sail acts as an expansion mechanism to expand theanchor when exposed to blood flow. In some embodiments, the anchor hasits inlet coated with a hydrogel coating which swells upon contact withblood and acting to expand the inlet of filter.

The filter devices of Berrada can be used in place of, or in combinationwith, the anchors described herein. Referring now to FIG. 88O, theanchor 434 can be an everting filter. Everting filter includes aflexible, mesh, filter body. The filter body may be formed of aplurality of wires or strands which can be used to form the mesh filterbody through a variety of methods, for example, braiding, knitting,weaving, helically winding, and counterwinding. The mesh can be fused atsome or all of the fiber or strand intersection points. The mesh canalso be electrospun, and formed of sheet or film having holes formed bylaser drilling, punching, dissolving components selectively, and thelike. The strands can be formed of material such as wire, which can bemetallic wire or polymeric wire. The wire may be substantially circularin cross section or may have any number of square, rectangular orirregular cross sectional profiles. The mesh is preferablyself-expanding. The self-expanding mesh can be formed totally or in partfrom self-expanding Nitinol, Elgiloy, titanium, or stainless steel wiresand the like, and combinations thereof. The self-expanding mesh can alsobe formed of engineering polymers, for example, liquid crystal polymer,PEEK, polyimide, polyester, and the like. A preferred mesh is formed ofNitinol wires, which can be heat set to the desired expanded shape. Themesh can preferably be heat set to a desired bias shape. Another mesh ishighly elastic, and preformed by mechanical overstress to the desiredexpanded shape. The mesh is preferably made radiopaque by means ofplating, core wires, tracer wires, or fillers that have good X-rayabsorption characteristics compared to the human body. The mesh may beeither partly or totally radiopaque.

The filter body may be seen to have a plurality of pores or openingsbetween the filter body strands or wires. The pores have an average poresize over the filter body, where the individual pore sizes may varydepending upon the location over the filter body. The filter body alsohas a proximal opening formed in filter body proximal region. The filterbody may also be considered to have an interior within the filter bodyand an exterior defined outside of the filter body. The everted shape offilter defines an everted cavity or concave region bounded by filterbody everted surface region or cavity side walls and the filter bodydistal-most extent. It may be seen from inspection of FIG. 88O thataxially translating proximal ring relative to distal ring while holdingthe filter body diameter consistent may change the degree of eversion offilter body. The filter material occupying distal-most region maytherefore change with the degree of eversion of filter, with differentlocations of filter body being distal-most varying as a function of thedegree of eversion. The length of a distal cavity will increase withincreasing eversion.

The filter devices of Paul can be used in place of, or in combinationwith, the anchors described herein. Referring now to FIGS. 88P-88Q, theanchor 435 and anchor 436 are everted. The anchor 435 is everted to forma proximally facing concave geometry. The filter portion may be evertedby moving the control wires proximally, thereby pulling the first end ofthe filter portion back over the rest of the filter portion. Further,the filter portion may also be made of a shape memory material such thatthe filter portion has two defined geometries. For example, the meshmaterial may be made of a shape memory alloy so that the mesh materialis biased into a straight tubular geometry in a non-everting state at afirst temperature. The first temperature being controlled, for example,by fluid flowing through the guiding member across the medical device.At a second temperature, such as the ambient temperature inside thevessel, the filter portion is biased into a proximally facing concavegeometry. When the filter portion is biased into the proximally facingconcave geometry, the filter portion everts causing the filter portionlto expand against the inner wall of the vessel. While the medicaldevice is expanded against the inner wall of the vessel, the filterportion serves to collect emboli that may break free from the stenosedarea preventing such emboli from blocking smaller vessels downstream ofthe medical device. When everted, the first end of the filter portion isbiased against the inner wall of the vessel forcing the fluid to flowthrough the proximally facing concave geometry formed by the filterportion. Therefore, emboli are trapped in the distal region of theproximally facing concave geometry. The medical device remains in thisexpanded state during the interventional procedure to capture any embolithat break free from the stenosis. After the interventional procedure iscompleted, the medical device may be removed. To trap the emboli in thefilter portion, the control wires may be pulled further proximallydrawing the filter portion against the guiding member.

For anchor 436, the control wires extend through the tubular geometry ofthe filter portion. Accordingly, the control wires form a framestructure along the length of the filter portion. The control wires maybe made of a synthetic material, a stainless steel, or a shape memoryalloy, such as Nitinol. The shape memory characteristics of the controlwire may be used to support the first end of the filter portion againstthe inner wall of the vessel. Supporting the filter portion against thewall of the vessel ensures that the fluid will flow through theproximally facing concave geometry formed by the everted filter portion,thereby causing emboli to be trapped by the medical device.

The cages of Krolik can be used in place of, or in combination with, theanchors described herein. Referring now to FIG. 88R, the anchor 437 caninclude a macerator cage. Generally, the macerator cage includes aclosed proximal or first end and an open distal or second end. The cagemay include a plurality of struts extending between the first and secondends and/or around a periphery of the cage, thereby defining acylindrical or other tubular outer wall including a plurality ofapertures.

The open distal end of the cage may include a plurality of distallyprotruding elements or distal tips 438. The cage includes at least twodifferent types of struts. For example, the cage may include a pluralityof relatively thick struts that extend substantially continuously alonga length of the cage e.g., in a first helical configuration between thefirst and second ends. In addition, the cage may include a plurality ofrelatively thin struts, which may connect adjacent thick strutstogether. As shown, the thin struts are not substantially continuous asare the thick struts, but may extend in a discontinuous patternhelically and/or circumferentially around the cage. Optionally, the thinstruts may also have bends or other features, e.g., relatively thinnedor perforated portions, that allow the struts to bend relatively easilycompared to the thick struts. The apertures may be defined by the spacesbetween the thick struts and the thin struts, thereby defining a desiredpore size for the cage.

The distal tips 438 on the open end may provide a substantiallyatraumatic distal end for the cage, e.g., to prevent puncture or otherdamage to a wall of a body lumen within which the cage is deployed. Inaddition or alternatively, the distal tips 438 may be sufficientlyflexible to allow the distal tips to twist helically and/or interlockwith one another during use. The distal tips 438 may facilitate engagingand/or removing obstructive material within a body lumen. Alternatively,the distal tip 438 can include a series of slots or indentations spacedapart along a length of the distal tip e.g., that may allow the distaltips to entangle with each other and/or with the obstructive materialcaptured or otherwise engaged by the distal tips to facilitate removal.For example, when the cage is rotated, the distal tips 438 andobstructive material may be wound together, e.g., such that portions ofother distal tips and/or obstructive material may enter the slots andthe distal tips 438 become interlocked with one another.

During distal advancement, the cage may be concurrently advanced androtated, e.g., manually or using a driveshaft. This may cause the distaltips 438 of the cage to track along the inside wall of the body lumen,e.g., in a helical manner as the cage is advanced. When thrombus orother obstructive material is encountered, the distal tips 438 may passbetween the material and the wall of the body lumen, thereby positioningthe material inside the cage. In some methods of use, the anchorsdescribed herein are rotated. In some methods of use, the anchorsdescribed herein are translated.

The distal tips 438 of the cage may facilitate separation and/or captureof material within the cage. For example, the edges of the distal tipsmay provide distal leading edges of the cage that are not asubstantially smooth cylinder but define an undulating surface.Consequently, the distal tips 438 of the cage may act as a saw byrepeatedly making contact with the material as the cage is rotated,which may increase the chance of material being dislodged from the wallof the body lumen and/or captured within the cage. To further ensurethat the leading edge of the cage passes between the unwanted materialand the wall of the body lumen, the distal tips 438 and/or edges of thestruts may also act as blades shearing along the wall of the body lumento draw adherent material into the cage. Thus, the struts may cut orotherwise separate the interface between the body lumen and theobstructive material.

The distal tips 438 may be formed such that they conform substantiallyto the cylindrical shape of the cage, e.g., defining a diameter similarto the rest of the expanded cage, although alternatively the distal tips438 may be biased radially outwardly, e.g., to ensure that the distaltips 438 pass between the wall of the body lumen and the obstructivematerial and/or enhance engagement of the distal tips against the wallof the body lumen. Alternatively, the distal tips 438 may by biased toextend radially inwardly, e.g., laterally inwardly, relative to acentral longitudinal axis of the apparatus, e.g., to prevent substantialrisk of damage to the wall of the body lumen.

The systems described herein are intended for use in any size vessel.The systems can be deployed in vessels with a diameter about 10 μm, 20μm, 30 μm, 40 μm, 50 μm, 60 μm, 70 μm, 80 μm, 90 μm, 100 μm, 200 μm, 300μm, 400 μm, 500 μm, 600 μm, 700 μm, 800 μm, 900 μm, 1 mm, 2 mm, 3 mm, 4mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25mm, between 1 mm and 8 mm, between 10 μm, and 1 mm, between 100 μm and 1mm, between 100 μm and 10 mm etc. The anchors can have a diameter orcross-section about 10 μm, 20 μm, 30 μm, 40 μm, 50 μm, 60 μm, 70 μm, 80μm, 90 μm, 100 μm, 200 μm, 300 μm, 400 μm, 500 μm, 600 μm, 700 μm, 800μm, 900 μm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm,11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19 mm, 20 mm, 21mm, 22 mm, 23 mm, 24 mm, 25 mm, less than 10 mm, less than 1 mm, lessthan 100 μm, less than 10 μm, etc. The ALTC device 201 can have adiameter or cross-section about 10 μm, 20 μm, 30 μm, 40 μm, 50 μm, 60μm, 70 μm, 80 μm, 90 μm, 100 μm, 200 μm, 300 μm, 400 μm, 500 μm, 600 μm,700 μm, 800 μm, 900 μm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm,9 mm, 10 mm, 11 mm, 12 mm, 13 mm, 14 mm, 15 mm, 16 mm, 17 mm, 18 mm, 19mm, 20 mm, 21 mm, 22 mm, 23 mm, 24 mm, 25 mm, less than 10 mm, less than1 mm, less than 100 μm, less than 10 μm, etc., or ranges incorporatingany two of the aforementioned values. It is contemplated that differentsizes of the systems will be available for selection by the user basedon the obstruction and the target vessel.

A perspective view of another embodiment of a capture system is shown inFIG. 89. FIG. 89 also illustrates non-limiting examples of variouspossible elements that can be included in a material capture system,according to some embodiments described herein. As illustrated in FIG.89, included in some embodiments are any number of, such as one, two, ormore of the following components: a thrombus capturing device or ALTCdevice 201 having any of the features described herein, e.g., a pusherwire or inner pusher 202, a first tubular member such as an outer sheath(not shown), and an anchor such as any of the anchors described herein.FIG. 89 illustrates an anchor 450. In some embodiments, the ALTC device201 can attach to the anchor 450. In some embodiments, the anchor 450functions as the capture guide 204 described herein. In someembodiments, the anchor 450 comprises a metallic material, such asNitinol. The anchor 450 can be in the form of, for example, a loop, asshown, or any closed shape including an oval, ellipse, or polygon. Theanchor 450 can be in the form of an open shape such as any linear ornon-linear segment. The ALTC device 201 and the anchor 450 can becoupled such as being sutured together. The ALTC device 201 and theanchor 450 can be encapsulated in a low durometer polymeric material.The anchor 450 can be coupled to the outer sheath 203. The proximal endof the ALTC device 201 can be coupled to an inner pusher 202 asdescribed herein. The anchor 450 can have any of the features of anchorsdescribed herein, including anchor 401.

The anchor 450 can be connected to an anchor pusher 451. The anchorpusher 451 can, in some embodiments, be an elongate tubular member witha central lumen therethrough, and have a proximal end and a distal end,both shown in FIG. 89. The distal end of the anchor pusher 451 can beoperably connected to the anchor 450 (e.g., tubular mesh as describedherein). In some embodiments, anchor 450 can be fixed or stationary withrespect to the anchor pusher 451. In some embodiments, anchor 450 can bemove axially with respect to the anchor pusher 451. The proximal end caninclude any number of, such as one, two, or more of the followingcomponents: a hemostasis assembly 206, a flush port 207, and a collapsedsegment 208. The anchor pusher 451 extends proximally and can be coupledto the hemostasis assembly 206. The anchor pusher 451 extends proximallyand can be coupled to a luer. In some embodiments, the anchor pusher 451can have a lumen to allow passage of a guidewire. In some embodiments,the anchor pusher 451 is a solid shaft.

FIG. 89 also shows the distal end of the ALTC device 201 in a deployedconfiguration. In some methods of use, a portion of the ALTC device 201is axially extended while the remaining length of the ALTC device 201 iscollapsed and contained within a sheath as previously described. In somemethods of use, the ALTC device 201 can be collapsed and tracked througha sheath or guide catheter (not shown) to the intended treatment area.In some embodiments, the guide catheter can be retracted proximally toinitially deploy the ALTC device 201 and the self expandable anchor 450.For instance, the retraction of the guide catheter can cause the anchor450 to expand. The anchor 450 can include a compressed or constrainedconfiguration while within the guide catheter. During the initialdeployment, the anchor 450 is released from a constrained position to aneutral position. In the neutral position, the anchor 450 creates aperimeter for the ALTC device 201. In the case of a loop or othercircular configuration, the anchor 450 can create a constant diameter.In the case of other shapes or configurations, the anchor 450 can createa constant cross-section. Alternatively or in combination, in othermethods of use, the ALTC device 201 can be advanced distally from theguide catheter to deploy the ALTC device 201.

In some cases, only a small fractional portion of the ALTC device 201,such as less than about 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, 10%, 5%,or less of the axial length of the device can be initially deployed. Thesmall portion can correspond to an amount of the ALTC device 201 whichallows the anchor 450 to assume the neutral position. During thedeployment of the anchor 450, a length of the ALTC device 201 can beretained within the outer sheath 203. The ALTC device 201 can follow acurve from the anchor 450 to the outer sheath 203. Retracting the outersheath 203 can lengthen the ALTC device 201 while maintaining a constantdiameter or cross-section provided by the anchor 450. In someembodiments, the proximal end of the ALTC device 201 is fixed relativeto the anchor 450. In some embodiments, the ALTC device 201 can axiallylengthen by releasing the compressed portion 208 as described herein. Insome methods of use, the ALTC device 201 is axially lengthened. In somemethods of use, the ALTC device 201 is not axially lengthened. The ALTCdevice 201 can serve as distal protection without further axiallylengthening. In some embodiments, the ALTC device 201 is deployed beforethe anchor 450. In some embodiments, the ALTC device 201 is deployedafter the anchor 450.

FIG. 89 illustrates a system including a dual ALTC device 201 and anchor450. The anchor functions to replace the nitinol. In some methods ofuse, the ALTC device 201 and the anchor 450 retract together. In somemethods of use, the ALTC device 201 and the anchor 450 move as a unit.In some embodiments, the distal end consists of axial lengthen devicewherein the opening end attaches to an expandable anchor. The ALTCdevice 201 comprises a proximal opening. In some embodiments, thecapture guide 204 is replaced with an anchor, such as anchor 450. Theproximal opening of the ALTC device 201 is coupled to the anchor 450such that the ALTC device 201 and the anchor move together. In someembodiments, the distal end of the axial lengthen device is fixed to thepusher 202 that extends proximally. The ALTC device 201 can be coupledto the pusher 202. The pusher 202 can push the compressed portion 208from the sheath 451 to cause axially lengthening of the ALTC device 201.The pusher 202 can extend to the proximal end of the system to becontrolled by the user. In some embodiments, the proximal end of theexpandable anchor attaches a pusher tube 451 extending proximally andattaches to a hemostasis housing. In some embodiments, the proximal endof the anchor 450 is coupled to the anchor pusher 451. The anchor pusher451 can extend proximally and attach to the hemostasis housing asdescribed herein. The system can be designed for thrombectomy. Thesystem can include a distal basket or ALTC device 201 and anchor 450.The anchor 450 can be made of wireform, laser cut or stent-likestructure. The materials can be such as shape memory, stainless steel,Cobalt Chromium.

FIG. 90 illustrates the distal end of the system of FIG. 89. The systemincludes the ALTC device 201 and the expandable anchor 450. In someembodiments, the ALTC device 201 and the anchor 450 are fixed and moveas one unit. In some embodiments, the distal end of the expandableanchor 450 attaches to the opening end of the ALTC device 201. In someembodiments, the proximal end of the anchor 450 attaches to the cathetershaft 451. In some embodiments, the distal end of the ALTC device 201extends through the anchor 450. In some embodiments, the distal end ofthe ALTC device 201 extends through the anchor 450 centrally or along alongitudinal axis. In some embodiments, the distal end of the ALTCdevice 201 extends through the anchor 450 along an axis offset from thelongitudinal axis of the anchor 450. The distal end of the ALTC device201 can be the compressed portion 208 as described herein. In someembodiments, the distal end of the ALTC device 201 is coupled to apusher wire 202. In some embodiments, the distal end of the ALTC device201 is coupled to the pusher wire 202 or other device described herein.

In some embodiments, alternatively, the distal end of the expandableanchor 450 is separated from the opening end of the ALTC device 201. Insome embodiments, the proximal end of the expandable anchor 450 attachesto distal end of catheter shaft. In some embodiments, the body of theALTC device 201 extends through the anchor 450 centrally and attaches tothe pusher 202. The pusher 202 can be contained within the pusher tube451, sheath 203, dual lumen sheath 243 or other constraining memberdescribed herein. The anchor 450 can be designed to collapse within thepusher tube 451. The ALTC device 201 can be designed to collapse withinthe pusher tube 451. In some methods of use, the ALTC device 201 can bereleased from the pusher tube 451 by proximal movement of the pushertube 451. In some methods of use, the anchor 450 can be released byproximal movement of the pusher tube 451. In some methods of use, theALTC device 201 can be released from the pusher tube 451 by distalmovement of the pusher 202. In some methods of use, the anchor 450 canbe released by distal movement of the pusher 202.

FIG. 91 illustrates another embodiment of a capture system, which canhave any of the features described herein. The capture system includesan anchor 452. The anchor 452 can have any of the features of anchorsdescribed herein, including anchor 405. A portion of the anchor 452 canbe contained within the pusher tube 451. In some embodiments, the ALTCdevice 201 can attach to the anchor 452 as described herein.

FIG. 92 illustrates another embodiment of a capture system, which canhave any of the features described herein. The capture system includesan anchor 453. In some embodiments, the ALTC device 201 can attach tothe anchor 453 as described herein. In some embodiments, the anchor 453is formed as a stent structure. The anchor 453 can includes a pluralityof struts. Each strut can be connected to the ALTC device 201 at one ormore locations. In the illustrated embodiment, each strut is connectedto the ALTC device 201 at two locations but other configurations arecontemplated (e.g., one location, three locations, four locations, fivelocations, a plurality of locations, etc.). In some embodiments, thestruts can be equally spaced. In some embodiments, the struts are notequally spaced. In some embodiments, the struts can include a zig-zagpattern or bends 454. In some embodiments, the bends 454 can improveflexibility of the capture system. In some embodiments, the bends 454can allow the capture system to turn. In some embodiments, the bends 454can be located near a proximal end of the anchor 453. In someembodiments, the bends 454 can be located near a distal end of theanchor 453. In some embodiments, the struts of the anchor 453 assist inretrieving and containing the obstruction or clot. In some embodiments,the struts comprise a shape memory or self-expanding material such asnitinol. In some embodiments, the anchor 453 can be self-expanded.

FIGS. 93-94 illustrate another embodiment of a capture system, which canhave any of the features described herein. The capture system includesanchor 455. In some embodiments, the struts 456 of the anchor 455 can bestraight. In some embodiments, the struts 456 can include a straightportion. In some embodiments, the straight portion in near a proximalend of the anchor. FIGS. 93-94 illustrates the axial lengthening of theexpanded portion of the ALTC device 201. The ALTC device 201 islengthening proximally. The compressed or constrained segment of theALTC device 201 is shortened within the pusher tube 241. In someembodiments, the pusher tube 241 can be retracted to axially lengthenthe ALTC device 201, as described herein. The ALTC device 201 and theanchor 455 can be retracted as a unit. FIG. 93 illustrates the axiallengthening device and the expandable anchor in the initialconfiguration. FIG. 94 illustrates the axial lengthening device and theexpandable anchor wherein the axial lengthening device is lengthened.

FIG. 95 illustrates another embodiment of a capture system, which canhave any of the features described herein. The capture system includesan anchor 457. In some embodiments, a portion of the anchor 457 isconnected to the ALTC device 201. The anchor 457 can include one or moredistal tips 458. In some embodiments, one or more distal tips 458 arenot connected to the ALTC device 201. The distal tips 458 can functionas distal tips described herein.

The distal tips 458 may provide a substantially atraumatic distal end,e.g., to prevent puncture or other damage to a wall of a body lumenwithin which the anchor 457 is deployed. The distal tips 458 mayfacilitate engaging and/or removing obstructive material within a bodylumen. Alternatively, the distal tips 458 can entangle with each otherand/or with the obstructive material captured or otherwise engaged bythe distal tips 458 to facilitate removal. The distal tips 458 mayfacilitate separation and/or capture of material. The distal tips 458ofthe anchor 457 may act as a saw by repeatedly making contact with thematerial, which may increase the chance of material being dislodged fromthe wall of the body lumen and/or captured within the anchor 457. Tofurther ensure that the leading edge of the anchor 457 passes betweenthe unwanted material and the wall of the body lumen, the distal tips458 and/or edges may also act as blades shearing along the wall of thebody lumen to draw adherent material into the anchor 457. Thus, thedistal tips 458 may cut or otherwise separate the interface between thebody lumen and the obstructive material. The distal tips 458 may beformed such that they conform substantially to the cylindrical shape ofthe ALTC device 201, e.g., defining a diameter similar to the rest ofthe ALTC device 201. In some embodiments, the distal tips 458 may bebiased radially outwardly or biased to extend radially inwardly. Otherconfigurations of the distal tips 458 are contemplated.

In some embodiments, the systems described herein comprise a fixed ALTCdevice 201. In some embodiments, the ALTC device 201 is inserted intothe patient in the initial configuration. For instance, the captureguide 204 described herein can be fixed such that the ALTC device 201assumes the initial configuration. In some embodiments, the ALTC device201 does not lengthen. In some embodiments, the axial length of the ALTCdevice 201 is fixed. In some embodiments, the anchor is fixed. In someembodiments, the anchor is inserted into the patient in the expanded orinflated configuration. In some embodiments, the anchor does not expandor inflate within the body of the patient. In some embodiments, theanchor has a fixed shape or configuration. In some embodiments, thesystem includes a clot buster or debulking at the front end. In someembodiments, the clot buster moves distally to break apart the clot. Insome embodiments, the clot buster is a portion of the anchor. In someembodiments, the clot buster is separate device.

FIGS. 96A-96B illustrate an expandable guide catheter 460. The guidecatheter 460 includes an expandable distal end, configured to bepositioned away from a user, within a body of a patient. The guidecatheter 460, or at least the distal end, can feature at least a dualbraid layer including an outer layer and an inner layer. In someembodiments, the expandable guide catheter 460 can include a dual layerstructure. In some embodiments, the expandable guide catheter 460 caninclude an outer braid layer 461. In some embodiments, the outer braidlayer 461 is coated with a material such as one or more polymericmaterials. In some embodiments, the expandable guide catheter 460 caninclude an inner braid layer 462. In some embodiments, the inner braidlayer 462 is not coated with a polymeric material. In some embodiments,a portion of the inner braid layer 462 is not coated. In someembodiments, a distal portion of the inner braid layer 462 is notcoated. In some embodiments, a length of the inner braid layer 462 isnot coated. In some embodiments, the entire length of the inner braidlayer 462 is not coated. In some embodiments, a portion of the outerbraid layer 461 is coated. In some embodiments, a distal portion of theouter braid layer 461 is coated. In some embodiments, a length of theouter braid layer 461 is coated. In some embodiments, the entire lengthof the outer braid layer 461 is coated. In some embodiments, the outerbraid layer 461 remains coated or encased with the polymer during theprocedure.

In some embodiments, the outer braid layer 461 is coated with a polymer.The polymer can be any material including Pellethane, Silicone,Tecoflex, Tecothane, Latex, Pebax. The polymer can function akin to aslip layer. The polymer can facilitate the sliding of the catheteragainst a target vessel. In some embodiments, the inner braid layer 462is not coated with a polymer, instead, retains the mesh-like structureas shown. The inner braid layer 462 advantageously provides decreasedsurface area, decreased surface contact, and/or decreased frictionrelative to an object within the lumen of the catheter. For instance,the mesh-like structure of the inner braid layer 462 has less surfacearea to contact the object within the lumen than a solid, inner wall.The inner braid layer 462 allows for a retrieval catheter, one or moreanchors, the obstruction, or the ALTC device 201 to more easily slideaxially when withdrawn proximally through the lumen. In some methods ofuse described herein, the ALTC device 201 can be axially lengthened overone or more anchors before retraction into the guide catheter 406. Insome methods of use described herein, the ALTC device 201 can be axiallylengthened over an obstruction such as a clot before retraction into theguide catheter 406. In some methods of use described herein, the ALTCdevice 201 can provide distal protection as the ALTC device 201 isretracted into the guide catheter 460.

In some embodiments, the guide catheter 460 has a funnel shape at thedistal end. In some embodiments, distal refers to the portion of theguide catheter 460, or component thereof, which is furthest from theuser during use, while proximal refers to the portion of the guidecatheter 460 or component thereof which is closest to the user. In someembodiments, the distal end of the guide catheter 460 is positionedwithin the body of the patient and the proximal end is outside the bodyof the patient.

In some embodiments, the expandable guide catheter 460 can include anyof the features of the ALTC device 201 described herein. In someembodiments, the mesh can be made from metallic materials such asindividual non-elastic wires. In some embodiments, the mesh can be madefrom elastic elements. In some embodiments, the mesh can be made from acombination of elastic and non-elastic wires. In some embodiments, thedual braid can be made of either polymeric or metallic materials. Insome embodiments, the metallic materials can be Nitinol, stainlesssteel, steel, shape memory alloy, elastic alloy, Nickel Titanium alloy,etc. In some embodiments, the braid wire diameter can range from 0.0005″to 0.030″, e.g., 0.0005″, 0.001″, 0.0015″, 0.002″, 0.0025″, or 0.003″,between 0.0005″-0.0015″, between 0.001″-0.002″, between 0.0015″-0.0025″,between 0.002″-0.003″ etc. Other configurations of braid wire diameterare contemplated. The braid wire can be woven in any pattern. In someembodiments, the guide catheter 460 can include at least one polymerlayer. The at least one polymer layer can applied to any surface of thebraid wire. The braid wire can include one or more woven patterns, forinstance a first wave pattern in a first portion of the guide catheter460 and a second wave pattern in a second portion of the guide catheter460. The woven pattern can be a typical over under pattern, e.g., twoover, two under; one over, one under, etc. The woven paten can from atubular braid. In some embodiments, the guide catheter 460 can includemultiple layers of braid wire.

The braid wire can form a mesh. In some embodiments, the cross-sectionof the wire can be any shape including round, polygonal, elliptical,etc. The shape of the wire can be flat, square, ribbon, round, etc. Insome embodiments, the total braid angle can range from 10 degrees to 170degrees. In some embodiments, the total braid angle is 0 degrees, 10degrees, 20 degrees, 30 degrees, 40 degrees, 50 degrees, 60 degrees, 70degrees, 80 degrees, 90 degrees, 100 degrees, 110 degrees, 120 degrees,130 degrees, 140 degrees, 150 degrees, 160 degrees, 170 degrees, 180degrees, between 0-45 degrees, between 45-90 degrees, between 90-135degrees, between 135-180 degrees, etc. In some embodiments, the braiddensity can range from 5 PPI to 60 PPI. In some embodiments, the braiddensity is less than 5 PPI, 5 PPI, 10 PPI, 15 PPI, 20 PPI, 25 PPI, 30PPI, 35 PPI, 40 PPI, 45 PPI, 50 PPI, 55 PPI, 60 PPI, 65 PPI, 70 PPI, 75PPI, 80 PPI, between 0-20 PPI, between 20-40 PPI, between 40-60 PPI,between 60-80 PPI, etc. In some embodiments, the inner diameter canrange from 1 F to 30 F. In some embodiments, the inner diameter is lessthan 1 F, 1 F, 2 F, 3 F, 4 F, 5 F, 6 F, 7 F, 8 F, 9 F, 10 F, 11 F, 12 F,13 F, 14 F, 15 F, 16 F, 17 F, 18 F, 19 F, 20 F, 21 F, 22 F, 23 F, 24 F,25 F, 26 F, 27 F, 28 F, 29 F, 30 F, 31 F, 32 F, 33 F, 34 F, 35 F,between 0 F-5 F, between 5 F-10 F, between 15 F-20 F, between 20 F-25 F,between 25 F-30 F, between 30 F-35 F, etc. In some embodiments, theouter diameter can range from 2 F up to 33 F. In some embodiments, theouter diameter is less than 1 F, 1 F, 2 F, 3 F, 4 F, 5 F, 6 F, 7 F, 8 F,9 F, 10 F, 11 F, 12 F, 13 F, 14 F, 15 F, 16 F, 17 F, 18 F, 19 F, 20 F,21 F, 22 F, 23 F, 24 F, 25 F, 26 F, 27 F, 28 F, 29 F, 30 F, 31 F, 32 F,33 F, 34 F, 35 F, between 0 F-5 F, between 5 F-10 F, between 15 F-20 F,between 20 F-25 F, between 25 F-30 F, between 30 F-35 F, etc.

In some embodiments, the expandable guide catheter 460 can include ashaft. In some embodiments, the expandable guide catheter 460 caninclude a shaft that expands under compression. In some embodiments, theexpandable guide catheter 460 can include a shaft that lengthens undercompression. In some embodiments, the expandable guide catheter 460 caninclude a shaft that expands upon release of a constraint. In someembodiments, the expandable guide catheter 460 can include a shaft thatexpands due to temperature. In some embodiments, the expandable guidecatheter 460 can include a shaft that expands to assume a neutralconfiguration.

In some embodiments, the expandable guide catheter 460 can include aninverted structure. In some embodiments, one end of the braid begins atthe proximal end and extends to the distal end where it folds inward andextends back to the proximal end. In some embodiments, the dual braidextends from the proximal end to the distal end. In some embodiments,the braid at the distal end can be continuous. In some embodiments, thebraid at the distal end can be discontinuous. In some embodiments, oneend of the braid begins at the proximal end and extends to the distalend wherein it folds inward and extends back to the proximal region. Insome embodiments, one end of the braid begins at the proximal end andextends to the distal end wherein it folds outward and extends back tothe proximal region. The outer braid layer 461 and the inner braid layer462 are concentric.

In some embodiments, the outer layer braid 461 is encapsulated withpolymeric materials. In some embodiments, the polymer layer can haveuniform wall thickness. In some embodiments, the polymer layer can haveuniform density. In some embodiments, the polymer layer can have uniformwall thickness throughout the entire catheter length. In someembodiments, the polymer layer can have non-uniform wall thickness. Insome embodiments, the proximal end of the catheter wall thickness isthicker than the wall thickness at the distal end. In some embodiments,the polymeric material can have the same softness (durometer) throughthe catheter length. In some embodiments, the polymeric material canhave different or a variety of softness (durometer) through the catheterlength. In some embodiments, the polymeric material is expandable. Insome embodiments, the polymeric material is flexible. In someembodiments, the outer layer composite is expandable. In someembodiments, polymeric materials can be any elastomer materials such asPolyurethane, Pellethane, Silicone, Tecoflex, Tecothane, Latex, Pebaxand/or combination thereof. In some embodiments, the polymer can becoupled to the braid material through any methods known in the art. Insome embodiments, the polymer can be coated, molded, dipped or thermallyfused onto the braid.

In some embodiments, the guide catheter 460 has a funnel shape at distalend. In some embodiments, the guide catheter outer braid is encapsulatedfrom the proximal end to the distal end near the funnel. In someembodiments, the funnel outer and inner braid layer is not encapsulatedwith polymer. In some embodiments, the funnel outer braid isencapsulated with polymer. In some embodiments, the inner braid layercan be encapsulated with polymer and the outer layer is not.

The guide catheter 460 can function as an access system. In someembodiments, the guide catheter 460 is introduced in a compresseddiameter configuration. In some embodiments, after introduction, theguide catheter 460 may be radially expanded to accommodate passage oflarger diameter surgical instruments therethrough such as ALTC device201 and/or the anchors described herein.

The guide catheter 460 can be useful for forming and enlarging accessarea in target locations within a patient's body. In some embodiments,the guide catheter 460 is delivered in a small diameter configurationand expanded. In some embodiments, only a distal end or a funnel end isexpanded. In some embodiments, the guide catheter 460 can change thesize of the lumen that the guide catheter 460 is inserted into, such asenlarging a vessel by pressing against the vessel wall. The guidecatheter 460 can include a polymeric coating that facilitates slidingcontact with the vessel wall.

In some embodiments, passage of the ALTC device 201 through the guidecatheter 460 can cause expansion of the guide catheter 460. In someembodiments, the collapsed ALTC device 201 can be sized to fit withinthe guide catheter 460. In some embodiments, the expanded ALTC device201 can be sized to fit within the guide catheter 460. In someembodiments, the expanded ALTC device 201 can be retracted through theguide catheter 460. In some embodiments, the one or more expandedanchors can be retracted through the guide catheter 460. In someembodiments, the one or more expanded anchors can be sized to fit withinthe guide catheter 460. The uncoated inner braid layer 462 reducessliding contact between the guide catheter 460 and any components passedtherethrough.

In some embodiments, the guide catheter 460 can function as a variablesized cannula. In some embodiments, the guide catheter 460 can functionas a tissue dilator. In some embodiments, the guide catheter 460 canchange shape during axial compression of the braid. In some embodiments,axial shortening can cause radial expansion of the guide catheter 460.In some embodiments, the guide catheter 460 can be variably expandedbased on the amount of compressive force. In some embodiments, the guidecatheter 460 is self-expanding. In some embodiments, the guide catheter460 is expanded by a mechanism e.g., pull strings, release from aconstraint, application of compressive force, application of tension,etc. In some embodiments, the guide catheter 460 is a shape memorymaterial.

In some embodiments, the guide catheter 460 can facilitate the removalof a blockage within the vasculature of a patient. In some embodiments,the guide catheter 460 can surround the one or more anchors that areentangled in the clot. In some embodiments, the surface of the clot canslide easily within the guide catheter, due in part, to the innersurface of the guide catheter 460. In some embodiments, the guidecatheter 460 can slide easily within the target vessel, due in part, tothe outer surface of the guide catheter 460. In some embodiments, theguide catheter 460 can be collapsed after receiving the one or moreanchors. In some embodiments, the guide catheter 460 can surround theALTC device 201 which itself encapsulates the obstruction. In someembodiments, the outer surface of the ALTC device 201 can slide easilywithin the guide catheter, due in part, to the inner surface of theguide catheter 460. In some embodiments, the guide catheter 460 can becollapsed after receiving the ALTC device 201.

Systems and methods can be utilized or modified for use in connectionwith those described herein can be found, for example, in U.S. patentapplication Ser. No. 11/101,224, filed Apr. 7, 2005 and published Jul.2, 2013 as U.S. Pat. No. 8,475,487 (“Bonnette”); U.S. patent applicationSer. No. 12/738,702, filed Oct. 27, 2008 and published Oct. 21, 2010 asU.S. Patent Pub. No. 20100268264 (“Bonnette ‘264”) are all incorporatedby reference herein in their entireties.

In some methods of use, the ALTC device 201 is used in combination witha thrombectomy catheter, such as an AngioJet® thrombectomy device orpotentially an aspiration catheter may be used to remove the embolicdebris. In some methods of use, one or more anchors described herein isused in combination with a thrombectomy catheter or an aspirationcatheter, such as an AngioJet® thrombectomy device. The use of theAngioJet®, a rheolytic cross stream thrombectomy catheter, can includean inherent ability to remove thrombus of larger diameter than thecatheter's diameter. However, the disruptive strength of the devicefalls off with the radial distance from the catheter. Hence, at someradial distance the clot can be stronger than the disruptive forcegenerated by the AngioJet® cross stream flow patterns. In the case oforganized thrombus, this radial distance from the catheter can besmaller than for softer thrombus.

Water jet thrombectomy procedures in general can be limited in abilityin some cases. However, adding mechanical disruption such as by use ofthe anchors described herein can unexpectedly and synergisticallyimprove water jet ablation. By combining mechanical agitation, e.g.,abrasive intimate contact of thrombus by a flexible and expandableanchor component and an ALTC device 201, with a rheolytic thrombectomycatheter (AngioJet®), a variety of thrombus can be cleared than can becleared by mechanical agitators or rheolytic cross stream thrombectomycatheters individually.

Another aspect and feature of some embodiments of the devices of thepresent disclosure is a device having the ability to capture large andsmall embolic debris. Another aspect and feature of the devices of thepresent disclosure is a device having the ability to temporarily capturedebris which may later be removed by manual aspiration or by the use ofan AngioJet® thrombectomy device and catheter or which may be treated bythrombolytics. Another aspect and feature of the devices of the presentdisclosure is a device having the ability to macerate debris to aclinically insignificant size (depending on the area of the body) or toa size which can be pharmacologically treated or removed by anotherdevice, such as an AngioJet® thrombectomy device and catheter. Anotheraspect and feature of the devices of the present disclosure is a devicehaving the ability to macerate non-embolic debris, such as a stationarythrombus, by pulling the device through such an obstruction.

Systems and methods can be utilized or modified for use in connectionwith those described herein can be found, for example, in U.S. patentapplication Ser. No. 14/774,735, filed Mar. 17, 2014 and published Jan.28, 2016 as U.S. Pub No. 20160022290 (“Johnson”); U.S. patentapplication Ser. No. 13/741,845, filed Jan. 15, 2013 and published Jan.2, 2014 as U.S. Patent Pub. No. 20140005712 (“Martin”) are allincorporated by reference herein in their entireties.

An intravascular ultrasound (IVUS) transducer disclosed in Johnson canbe incorporated into the systems described herein. In some embodiments,an intravascular ultrasound (IVUS) transducer can be added to orincorporated into the delivery system and method. A pressure sensor canbe used to measure the pressure at various positions within thevasculature, which can be used to determine blood flow, while theintravascular ultrasound (IVUS) transducer can be used to measure fluidflow and/or provide imaging within the vessel. In some embodiments, thepressure sensor and/or IVUS transducer can be incorporated into theguidewire at one or more locations, such as the distal end or distalportion of a guidewire, as well as being incorporated into intermediateand proximal portions of the guidewire. The guidewire with the pressuresensor and/or the IVUS transducer can be used much like a normalguidewire to help navigate the delivery device through the vasculature,with the added benefit of providing pressure measurements and ultrasoundimaging to help in the navigation, to visualize the device placementsite, and to monitor and ensure proper device deployment. In someembodiments, the IVUS transducer generates image slices as it isadvanced and retracted which can then be assembled together to form athree dimensional reconstruction of the vasculature and/or the devicewithin the vasculature. In some embodiments, the guidewire with thepressure sensor and/or IVUS transducer can be fastened to a catheter ina similar manner to that described below for a catheter having apressure sensor and/or IVUS transducer that is fastened to anothercatheter.

Use of the ultrasound imaging system can allow the operator to deliverthe device without fluoroscopy or using less fluoroscopy, therebyreducing the radiation exposure to the patient, while allowing moreaccurate evaluation of the vasculature, aiding placement of the deviceand allowing confirmation that device placement was proper. The imagingcan be used to aid in the deployment of the filters or other devices.The imaging can also be used to aid in the retrieval of the deployeddevices by providing visualization of, for example, the retrievalfeatures on the deployed device and of the retrieval features, such asloops on a snare, of the retrieval device. The vasculature and implantlocation can be imaged prior to deployment, after deployment and/orduring deployment. The imaging can be used during the retrieval process.The imaging can be used to aid in positioning of the filter or devicewithin the vasculature. The imaging can be used to image the deploymentlocation and determine the appropriate sizing of the filter or otherdevice. The imaging can be used to help estimate treatment duration.

Although imaging systems described above have been primarily describedas ultrasound based, other imaging systems can be used instead or inaddition. For example, the imaging system can be based on intravascularultrasound (IVUS), Forward-Looking IVUS (FLIVUS), optical coherencetomography (OCT), piezoelectric micro-machined ultrasound traducer(PMUT), and/or FACT.

Other components described by Martin can also be incorporated into thesystems described herein. All or some of the device can be designed toincrease their ability to adhere to the obstruction. For example, thewires may be coupled to an energy source (e.g., RF, ultrasonic, orthermal energy) to “weld” to the obstruction. Application of energy tothe device can allow the surrounding portion to deform into theobstruction and “embed” within the obstruction. Alternatively, thedevice can impart a positive charge to the obstruction to partiallyliquefy the obstruction sufficiently to allow for easier removal. Inanother variation, a negative charge could be applied to further buildthrombus and nest the device for better pulling force. The wires can bemade stickier by use of a hydrophilic substance(s), or by chemicals thatwould generate a chemical bond to the surface of the obstruction.Alternatively, the filaments may reduce the temperature of theobstruction to congeal or adhere to the obstruction.

Another aspect applicable to variations of the devices can be toconfigure the devices (whether the traversing filament or thesurrounding portion) for better adherence to the obstruction. One suchmode includes the use of coatings that bond to certain clots (or othermaterials causing the obstruction.) For example, the wires may be coatedwith a hydrogel or adhesive that bonds to a thrombus. Accordingly, asthe device secures about a clot, the combination of the additive and themechanical structure of the device may improve the effectiveness of thedevice in removing the obstruction. Coatings may also be combined withthe capturing portions or catheter to improve the ability of the deviceto encapsulate and remove the obstruction (e.g., a hydrophilic coating).

Such improvements may also be mechanical or structural. Any portion ofthe capturing portion can have hooks, fibers, or barbs that grip intothe obstruction as the device surrounds the obstruction. The hooks,fibers, or barbs can be incorporated into any portion of the device.However, it will be important in some embodiments that such features donot hinder the ability of the practitioner to remove the device from thebody.

In addition to additives, the device can be coupled to an RF, microwave,magnetic, thermal, cryo, or other power source, to allow electrical,current, ultrasound or RF energy to transmit through the device andinduce clotting or cause additional coagulation of a clot or otherobstruction.

The methods described herein may also include treating the obstructionprior to attempting to remove the obstruction. Such a treatment caninclude applying a chemical or pharmaceutical agent with the goal ofmaking the occlusion shrink or to make it more rigid for easier removal.Such agents include, but are not limited to chemotherapy drugs, orsolutions, lytic agents such as tPA, urokinase, or streptokinase forexample, an anticoagulant, a mild formalin, or aldehyde solution.

Various other modifications, adaptations, and alternative designs are ofcourse possible in light of the above teachings. Therefore, it should beunderstood at this time that the inventions may be practiced otherwisethan as specifically described herein. It is contemplated that variouscombinations or subcombinations of the specific features and aspects ofthe embodiments disclosed above may be made and still fall within one ormore of the inventions. Further, the disclosure herein of any particularfeature, aspect, method, property, characteristic, quality, attribute,element, or the like in connection with an embodiment can be used in allother embodiments set forth herein. Accordingly, it should be understoodthat various features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the disclosed inventions. Thus, it is intended that the scopeof the present inventions herein disclosed should not be limited by theparticular disclosed embodiments described above. Moreover, while theinventions are susceptible to various modifications, and alternativeforms, specific examples thereof have been shown in the drawings and areherein described in detail. It should be understood, however, that theinventions are not to be limited to the particular forms or methodsdisclosed, but to the contrary, the inventions are to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described. Any methods disclosedherein need not be performed in the order recited. The methods disclosedherein include certain actions taken by a practitioner; however, theycan also include any third-party instruction of those actions, eitherexpressly or by implication. For example, actions such as “inserting acatheter transfemorally” includes “instructing the insertion of acatheter transfemorally.” The ranges disclosed herein also encompass anyand all overlap, sub-ranges, and combinations thereof. Language such as“up to,” “at least,” “greater than,” “less than,” “between,” and thelike includes the number recited. Numbers preceded by a term such as“approximately”, “about”, and “substantially” as used herein include therecited numbers (e.g., about 10%=10%), and also represent an amountclose to the stated amount that still performs a desired function orachieves a desired result. For example, the terms “approximately”,“about”, and “substantially” may refer to an amount that is within lessthan 10% of, within less than 5% of, within less than 1% of, within lessthan 0.1% of, and within less than 0.01% of the stated amount.

1-20. (canceled)
 21. A clot capture system, comprising: an expandableguide catheter; a tubular body comprising a first end, a second end, andan axial length therebetween, the first end having an opening, whereinthe tubular body is compressed in a first configuration, wherein thetubular body is transformable to a second configuration in which atleast the first end of the tubular body is expanded but the second endof the tubular body and a portion of the tubular body remainscompressed, and wherein the tubular body has a first expanded axiallength, wherein the tubular body is transformable to a thirdconfiguration in which the tubular body has a second expanded axiallength greater than the first expanded axial length, and wherein thetubular body in the third configuration is configured to be retractedthrough the expandable guide catheter.
 22. The clot capture system ofclaim 21, wherein the tubular body is configured to slide relative to aninner layer of the expandable guide catheter.
 23. The clot capturesystem of claim 21, wherein the expandable guide catheter is configuredto reduce sliding contact between the expandable guide catheter and anycomponents pass therethrough.
 24. The clot capture system of claim 21,wherein the expandable guide catheter is configured to function as avariably sized cannula.
 25. The clot capture system of claim 21, whereinthe expandable guide catheter is self-expanding.
 26. The clot capturesystem of claim 21, wherein the expandable guide catheter comprises adual layer structure.
 27. The clot capture system of claim 21, whereinthe expandable guide catheter comprises an inner braid layer and anouter braid layer.
 28. The clot capture system of claim 21, wherein theexpandable guide catheter comprises at least one coated layer.
 29. Theclot capture system of claim 21, further comprising an anchor.
 30. Theclot capture system of claim 21, further comprising two or more anchors,wherein the two or more anchors are spaced axially apart along alongitudinal axis.
 31. The clot capture system of claim 21, furthercomprising an anchor configured to entangle a clot.
 32. The clot capturesystem of claim 21, further comprising an anchor coupled to the tubularbody.
 33. A method of using a clot capture system, comprising:positioning a clot capture system near an obstruction, the clot capturesystem comprising: an expandable guide catheter; a tubular bodycomprising a first end, a second end, and an axial length therebetween,the first end having an opening, wherein the tubular body is compressedin a first configuration, transforming the tubular body to a secondconfiguration in which at least the first end of the tubular body isexpanded but the second end of the tubular body and a portion of thetubular body remains compressed, and wherein the tubular body has afirst expanded axial length; transforming the tubular body to a thirdconfiguration in which the tubular body has a second expanded axiallength greater than the first expanded axial length to encapsulate theobstruction; and retracting the tubular body through the expandableguide catheter.
 34. A clot capture system, comprising: a guide catheter;a shape memory tubular body comprising a first end, a second end, and anaxial length therebetween, the first end having an opening, wherein theshape memory tubular body is configured to be compressed duringdelivery, wherein the shape memory tubular body is transformable to aconfiguration in which the opening is expanded and a first segment ofthe shape memory tubular body extending axially from the opening isexpanded to a fold point, the first segment having a first expandedaxial length, and a second segment of the shape memory tubular bodyextending axially from the fold point to the second end of the shapememory tubular body such that the second segment of the shape memorytubular body extends at least partially within the first segment of theshape memory tubular body, wherein the second segment is relativelycompressed with respect to the first segment, wherein the shape memorytubular body is configured to be axially lengthened, wherein shapememory tubular body is configured to be retracted through the guidecatheter.
 35. The clot capture system of claim 34, wherein the guidecatheter comprises an expandable distal end.
 36. The clot capture systemof claim 34, wherein the guide catheter comprises a dual braid layer.37. The clot capture system of claim 34, wherein at least a portion ofthe guide catheter comprises a polymeric coating.
 38. The clot capturesystem of claim 34, wherein at least an outer portion of the guidecatheter comprises a coating.
 39. The clot capture system of claim 34,wherein at least a portion of the guide catheter comprises a mesh. 40.The clot capture system of claim 34, wherein at least an inner portionof the guide catheter provides decreased surface area, decreased surfacecontact, and/or decreased friction relative to an object within a lumenof the guide catheter.